chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: tiredness; This is a spontaneous report from a contactable consumer reported for herself that a 39-year-old female patient (not pregnancy) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number: ew0172), via an unspecified route of administration, administered in arm left on 30Apr2021 15:00 (at the age of 39-year-old) as 1st dose, single dose for COVID-19 immunisation.  Medical history included only allergies.  There were no concomitant medications.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  There were no other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient did not diagnose with COVID-19.  The patient did not been tested for COVID-19 post vaccination or since the vaccination.  The patient experienced tiredness on 05May2021 in between first dose and second dose.  No treatment received.  Outcome of the event was resolved in May2021.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Rash
Clinical narrative: His wife reported shingles after receiving the second dose of the Pfizer COVID-19; gotten a rash that covered most of her body after receiving Pfizer vaccine; This is a spontaneous report from a contactable consumer (patient's husband). A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: was not reported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history included varicella and herpes zoster when she was pregnant. The patient's concomitant medications were not reported. The patient had previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) on an unspecified date for COVID-19 immunization. It was reported that on an unspecified date in 2021 the caller was calling regarding his wife as his wife reported shingles after receiving the second dose of the Pfizer COVID-19 vaccine. Caller wanted to know if Pfizer can provide precaution recommendation or information for his 15-year son, so he did not get similar side effects as his mother. Caller stated he read an article in US. There were few reports of people who previously had chicken pox reporting an outbreak of shingles after receiving the vaccine. Caller also stated that his wife received the vaccine and gotten a rash that covered most of her body after receiving Pfizer vaccine and lasted for about a week. The outcome of shingles after receiving the second dose of the Pfizer COVID-19 was unknown while rash was recovered on unspecified date in 2021.  Information on the lot/batch number has been requested.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: This is a spontaneous report from a contactable consumer. A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 26Mar2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE DOSE, dose 2 via an unspecified route of administration on 16Apr2021 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE DOSE for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. Caller received her 1st Pfizer vaccine dose on 21 and she received her 2nd Vaccine dose on 16Apr2021. Caller states her menstrual cycle started the beginning of March/2021 and "then my cycle started the very next day right after I received the 1st vaccine dose. So, I had 2 menstrual cycles in March and none in April. Caller states she knows she is at the age for "menopause" but did not think it would happen this quickly. The outcome of the event was unknown. Follow-up needed. Information about batch/lot number has been requested.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Body height, Feeling abnormal, Headache, Malaise, Oral herpes
Clinical narrative: feeling horrible; Since the first dose he woke up with what mother states is herpes zoster on his lips; Arm hurt; headache; Tonsils hurt; didn't feel well; This is a spontaneous report from a contactable consumer (patient's mother). A 13-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Solution for injection, Lot number: EW0167, expiry date: Aug2021), dose 1 via an unspecified route of administration, administered in left arm on 13May2021 at 12:15, as 1st dose, single for COVID-19 immunization. The patient's medical history and other allergies compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity were none. The patient's concomitant medications were not reported. The patient had no family medical history relevant to AE. The patient received no other vaccinations within four weeks prior to the first administration date of the suspect vaccine. No additional vaccines administered on same date of the Pfizer Suspect. On 13Jan2021 at 20:00, 8 hours after getting the shot, the patient experienced tonsils started hurting. He didn't feel well and had headaches. On 14Jan2021, he had some pretty bad symptoms on Saturday morning, he woke up with herpes zoster on his lips and his mother called to pediatrician and he was very dismissive about it and said that if the body was under stress it can come out, but he never had anything like this before. It looks like little pustules around his mouth and looks like when my mom had shingles. He did mention his arm hurt a little but went to soccer practice. Clarifies the herpes zoster didn't show up until Saturday evening/night and it was starting to go away. She took son to get Covid PCR testing on 14Jan2021 and it was negative and was told that the herpes zoster was probably a reaction to the vaccine. The patient received treatment with Abreva. The outcome of the events Since the first dose he woke up with what mother states is herpes zoster on his lips was not recovered, and the other event feeling horrible was unknown, and all other events was recovering.   PSCC Communication: PC Filed Product Complaint: Yes, Description of Product Complaint: Description of complaint: Asks if this could be a bad one since he was so sick and took him to get Covid PCR testing and it was negative. Thought was weird since she and her husband both had the Pfizer Covid shot and did not have any reactions. This was son's first Covid vaccine, Lot number: EW0167, expiry.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, SARS-CoV-2 test, Tonsillitis, Weight
Clinical narrative: feeling horrible; Since the first dose he woke up with what mother states is herpes zoster on his lips; Arm hurt; headache; Tonsils hurt; didn't feel well; This is a spontaneous report from a contactable consumer (patient's mother). A 13-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Solution for injection, Lot number: EW0167, expiry date: Aug2021), dose 1 via an unspecified route of administration, administered in left arm on 13May2021 at 12:15, as 1st dose, single for COVID-19 immunization. The patient's medical history and other allergies compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity were none. The patient's concomitant medications were not reported. The patient had no family medical history relevant to AE. The patient received no other vaccinations within four weeks prior to the first administration date of the suspect vaccine. No additional vaccines administered on same date of the Pfizer Suspect. On 13Jan2021 at 20:00, 8 hours after getting the shot, the patient experienced tonsils started hurting. He didn't feel well and had headaches. On 14Jan2021, he had some pretty bad symptoms on Saturday morning, he woke up with herpes zoster on his lips and his mother called to pediatrician and he was very dismissive about it and said that if the body was under stress it can come out, but he never had anything like this before. It looks like little pustules around his mouth and looks like when my mom had shingles. He did mention his arm hurt a little but went to soccer practice. Clarifies the herpes zoster didn't show up until Saturday evening/night and it was starting to go away. She took son to get Covid PCR testing on 14Jan2021 and it was negative and was told that the herpes zoster was probably a reaction to the vaccine. The patient received treatment with Abreva. The outcome of the events Since the first dose he woke up with what mother states is herpes zoster on his lips was not recovered, and the other event feeling horrible was unknown, and all other events was recovering.   PSCC Communication: PC Filed Product Complaint: Yes, Description of Product Complaint: Description of complaint: Asks if this could be a bad one since he was so sick and took him to get Covid PCR testing and it was negative. Thought was weird since she and her husband both had the Pfizer Covid shot and did not have any reactions. This was son's first Covid vaccine, Lot number: EW0167, expiry.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Feeling abnormal, Herpes zoster, Pruritus
Clinical narrative: This is a spontaneous report from a contactable consumer reported (herself). A 78-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number & Expiry date not reported) via unspecified route of administration in left arm 28Apr2021 16:15 (at age of 78-years-old) as 1st dose, single dose for COVID-19 Immunization. Patient medical history includes ongoing blood pressure, ongoing (Gastroesophageal reflux disease) GERD reflux, ongoing back pain. Patient had allergies to things like hay fever, pollen, dust, mold. Historical vaccine include Shingles shot on unspecified date and experienced flu. If she had the booster, she would not have shingles. Patient past drug includes Zantac for about 6-8 months ago. Other conditions include scoliosis, has had back operations. She has lost a lot of height due to scoliosis. Patient concomitant medications include irbesartan used for prevention of high blood pressure from unspecified date and ongoing, metformin hydrochloride (METFORMIN ALPHARMA) (1000 mg, 1x/day frequency) used for preventative for Diabetes, she does not have Diabetes from unknown date and ongoing, Famotidine (20mg) taken for GERD reflux from 6 to 8 months from unspecified date, Vitamins taken from unspecified date and unknown till ongoing. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. On Apr2021, Patient experienced shingles, pain in her back, rash on lower back which are ongoing and does not feel great, itching or burning in her back was worse. She is unsure if it started the day before or the day of the vaccine. Patient received treatment for events by Mederol/ Methylprednisolone 4 mg for pain as prescribed by the doctor only taken for 1 day/ 6 pills. Also took an Advil the day before and the night of the shot. Patient didn't visit any emergency room but just called her physician. she had a rash on back which doctor confirmed was shingles. The patient had a side effect after the first dose of the vaccine. She asked should I get the second dose. The patient wanted to know if it is accurate that she can delay the 2nd dose up to 6 weeks. She is supposed to get her second dose of Pfizer Covid Vaccine this coming Wednesday, 19May2021, but she still has shingles and does not feel great. As noted in the Fact Sheet for Recipients, you should not get the Pfizer-BioNTech COVID-19 Vaccine if you had a severe allergic reaction after a previous dose of the vaccine or if you had a severe allergic reaction to any ingredient of the vaccine. In response to caller, they suggested to consult healthcare provider they know your health situation and has access to information that can better help inform this decision. Second Pfizer Covid Vaccine shot, she said it is scary, and the doctor said it was scary for her not to take it, all. The Outcome of events was recovering.    Follow up attempts are needed. Further information has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Burning sensation, Fatigue, Herpes zoster, Pain in extremity
Clinical narrative: Shingles; Really fatigued; Took a nap; Had a low grade fever; Getting a little rash to her left butt cheek and it got worse and was spreading and oozing; Oozing; Burning; Itching; Her 2nd dose is when this began and states she had soreness in her arm; This is a spontaneous report from a contactable consumer or other non hcp. A 44-years-old female patient received bnt162b2, dose 2 via an unspecified route of administration, administered in Arm Left on 28Apr2021 14:00 (Batch/Lot Number: EW0170) as 2ND DOSE, SINGLE for covid-19 immunization.  Patient had received her 1st dose of bnt162b2 vaccine (Batch/lot number: EW0158   administered left arm ) on 07Apr2021. Patients' Medical history was not known. Concomitant medications include multivitamins. The patient was not hospitalized, no Prior vaccinations were taken within 4 weeks, no AE prior to vaccinations, no Relevant tests were done. After 1st dose patient experienced sore arm. After her second dose patient experienced shingles- herpes zoster, fatigue, took a nap- somnolence, low grade fever- pyrexia, a little rash to her left butt cheek and it got worse and was spreading and oozing- skin weeping, burning sensation, itching- pruritus, soreness in her arm- pain in extremity. The patient underwent lab tests and procedures which included body temperature: 101 Fahrenheit. Patient took Tylenol for fever, antiviral medication for shingles, ointments like Neosporin (expiry date is Jul2022 and lot is 2210 LZ/1 imprinted on the bottle and the box has lot 2210LZ with UPC number 0081074688, and is dual action strength ointment and pain relief), Hydrocortisone 1% and is Cortisone 10 (expiry date Oct2023, lot 20L109 and UPC on the box of 4116703396) and it is water resistant itch relief. The outcome of events was unknown.    Follow-up (17May2021): This is a follow up spontaneous report received from a contactable consumer.  No new information was recorded. Information on Lot/Batch number was available. Additional information has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia, Rash, Skin weeping, Somnolence
Clinical narrative: Shingles; Really fatigued; Took a nap; Had a low grade fever; Getting a little rash to her left butt cheek and it got worse and was spreading and oozing; Oozing; Burning; Itching; Her 2nd dose is when this began and states she had soreness in her arm; This is a spontaneous report from a contactable consumer or other non hcp. A 44-years-old female patient received bnt162b2, dose 2 via an unspecified route of administration, administered in Arm Left on 28Apr2021 14:00 (Batch/Lot Number: EW0170) as 2ND DOSE, SINGLE for covid-19 immunization.  Patient had received her 1st dose of bnt162b2 vaccine (Batch/lot number: EW0158   administered left arm ) on 07Apr2021. Patients' Medical history was not known. Concomitant medications include multivitamins. The patient was not hospitalized, no Prior vaccinations were taken within 4 weeks, no AE prior to vaccinations, no Relevant tests were done. After 1st dose patient experienced sore arm. After her second dose patient experienced shingles- herpes zoster, fatigue, took a nap- somnolence, low grade fever- pyrexia, a little rash to her left butt cheek and it got worse and was spreading and oozing- skin weeping, burning sensation, itching- pruritus, soreness in her arm- pain in extremity. The patient underwent lab tests and procedures which included body temperature: 101 Fahrenheit. Patient took Tylenol for fever, antiviral medication for shingles, ointments like Neosporin (expiry date is Jul2022 and lot is 2210 LZ/1 imprinted on the bottle and the box has lot 2210LZ with UPC number 0081074688, and is dual action strength ointment and pain relief), Hydrocortisone 1% and is Cortisone 10 (expiry date Oct2023, lot 20L109 and UPC on the box of 4116703396) and it is water resistant itch relief. The outcome of events was unknown.    Follow-up (17May2021): This is a follow up spontaneous report received from a contactable consumer.  No new information was recorded. Information on Lot/Batch number was available. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles on my face; This is a spontaneous report from a 48-year-old female contactable consumer. This consumer (patient) reported.  A 48-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0170), via an unspecified route of administration in left arm on 26Apr2021 at 16:00 (at the age of 48-year-old) as a 1st dose, single dose for COVID-19 immunization. The patient's medical history included rheumatoid arthritis. The patient had no known allergies. The patient experienced COVID prior to the vaccination. The patient's concomitant medications included abatacept (ORENCIA) injection, methotrexate (METHOTREXATE). The patient did not receive any other vaccine in four weeks of COVID vaccine. The patient was not tested for COVID post vaccination. The patient did not receive any other vaccines 4 weeks prior to the COVID vaccine. On 28Apr2021, after 2 days of vaccination, the patient experienced shingles on my face. The patient received antiviral pills which were prescribed as treatment medication for the event. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the event was resolving.  Follow up attempts are needed. Further information has been requested.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Developed shingles 5 days after 2nd dose; This is a spontaneous report from a contactable consumer (patient) other hcp.   A 47-year-old female received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: Ew0179 Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 08May2021 08:00 (age at vaccination 47-year-old) as 2ND DOSE, SINGLE DOSE for COVID-19 immunisation. the patient received first dose of BNT162b2 (BNT162B2, Lot number: Ew0150 and Expiration date: unknown), administered in Arm Left on 19Apr2021 08:00 AM as first dose single doe for COVID-19 immunisation. Medical history included evans syndrome, rubber sensitivity, CVID (immunodeficiency common variable). The patient previously took doxycycline and experienced drug hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and not tested for COVID-19 since vaccination. Concomitant medication(s) included curcuma longa root (TURMERIC CURCUMIN), zingiber officinale root (GINGER ROOT [ZINGIBER OFFICINALE ROOT]) taken for an unknown indication from unknown dates and unknown if ongoing. On 13May2021, the patient experienced developed shingles 5 days after 2nd dose. adverse event result in patient visited Doctor or other healthcare professional office, clinic visit. Therapeutic measures were taken as a result of developed shingles 5 days after 2nd dose tried Valtrex. Developed shingles 5 days after 2nd dose. patient understand that this is not an allergic/anaphylactic reaction. she think this needs to be taken into consideration. The outcome of event was recovering.   Information on Lot/Batch number was available. Additional information has been requested
Sex: U
Vaccine: COVID19
Symptoms: Balance disorder, Headache, Hypoaesthesia, Lymph node pain, Lymphadenopathy
Clinical narrative: left hand was tingly/pins and needles/feeling lots of pins and needles in my left hand/tingling/ pins and needles in both hands and both legs/left foot and calf tingling; Hand numbness and tingling was very intense; hand numbness and tingling was very intense to the point that it hurt; Hand was tingly/pins and needles and kept me awake; Left arm weakness/ some weakness in my legs; Some loss of balance when walking occasionally; My left hand felt very cold; My left neck lymph node got tender and swollen; My left neck lymphnode got tender and swollen/ felt my lymph nodes in my neck and jaw somewhat swollen; Headache; Felt congested; This is a spontaneous report from a contactable consumer or other non hcp (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number, and Expiration date not reported), via an unspecified route of administration, administered in the left arm on 22Apr2021, as second dose, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 23Apr2021, the patient experienced my left neck lymph node got tender and swollen, my left neck lymph node got tender and swollen/felt my lymph nodes in my neck and jaw somewhat swollen. On an unspecified date in Apr2021, the patient experienced headache and felt congested. On an unspecified date in May2021, the patient experienced left hand was tingly/pins and needles/feeling lots of pins and needles in my left hand/tingling/ pins and needles in both hands and both legs/left foot and calf tingling, hand numbness and tingling was very intense, hand numbness and tingling was very intense to the point that it hurt, hand was tingly/pins and needles and kept me awake, left arm weakness/ some weakness in my legs, some loss of balance when walking occasionally, and my left hand felt very cold. Patient had 2nd Pfizer dose on 22Apr2021 in the left arm. Next day, patient's left neck lymph node got tender and swollen for few days. Few days later, patient had a headache and felt congested. During the first week, one night, patient's left hand was tingly/pins and needles and kept him/her awake. Then on 09May2021, he/she woke up with a headache and felt lymph nodes in neck and jaw somewhat swollen. He/She started feeling lots of pins and needles in left hand and some weakness in legs. Also felt some loss of balance when walking occasionally. Patient also noted his/her left hand felt very cold. Last night he/she woke up around 4AM with tingling/ pins and needles in both hands and both legs. They lasted until patient got up. Now, patient have tingling in left hand, left arm weakness and left foot and calf tingling. Patient was concerned about how these side effects are lasting. Patient stated he/she will make an appointment with a neurologist. Patient stated any insight would help. The outcome of all events was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Muscular weakness, Nasal congestion, Pain in extremity, Paraesthesia, Peripheral coldness
Clinical narrative: left hand was tingly/pins and needles/feeling lots of pins and needles in my left hand/tingling/ pins and needles in both hands and both legs/left foot and calf tingling; Hand numbness and tingling was very intense; hand numbness and tingling was very intense to the point that it hurt; Hand was tingly/pins and needles and kept me awake; Left arm weakness/ some weakness in my legs; Some loss of balance when walking occasionally; My left hand felt very cold; My left neck lymph node got tender and swollen; My left neck lymphnode got tender and swollen/ felt my lymph nodes in my neck and jaw somewhat swollen; Headache; Felt congested; This is a spontaneous report from a contactable consumer or other non hcp (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number, and Expiration date not reported), via an unspecified route of administration, administered in the left arm on 22Apr2021, as second dose, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 23Apr2021, the patient experienced my left neck lymph node got tender and swollen, my left neck lymph node got tender and swollen/felt my lymph nodes in my neck and jaw somewhat swollen. On an unspecified date in Apr2021, the patient experienced headache and felt congested. On an unspecified date in May2021, the patient experienced left hand was tingly/pins and needles/feeling lots of pins and needles in my left hand/tingling/ pins and needles in both hands and both legs/left foot and calf tingling, hand numbness and tingling was very intense, hand numbness and tingling was very intense to the point that it hurt, hand was tingly/pins and needles and kept me awake, left arm weakness/ some weakness in my legs, some loss of balance when walking occasionally, and my left hand felt very cold. Patient had 2nd Pfizer dose on 22Apr2021 in the left arm. Next day, patient's left neck lymph node got tender and swollen for few days. Few days later, patient had a headache and felt congested. During the first week, one night, patient's left hand was tingly/pins and needles and kept him/her awake. Then on 09May2021, he/she woke up with a headache and felt lymph nodes in neck and jaw somewhat swollen. He/She started feeling lots of pins and needles in left hand and some weakness in legs. Also felt some loss of balance when walking occasionally. Patient also noted his/her left hand felt very cold. Last night he/she woke up around 4AM with tingling/ pins and needles in both hands and both legs. They lasted until patient got up. Now, patient have tingling in left hand, left arm weakness and left foot and calf tingling. Patient was concerned about how these side effects are lasting. Patient stated he/she will make an appointment with a neurologist. Patient stated any insight would help. The outcome of all events was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality sleep
Clinical narrative: left hand was tingly/pins and needles/feeling lots of pins and needles in my left hand/tingling/ pins and needles in both hands and both legs/left foot and calf tingling; Hand numbness and tingling was very intense; hand numbness and tingling was very intense to the point that it hurt; Hand was tingly/pins and needles and kept me awake; Left arm weakness/ some weakness in my legs; Some loss of balance when walking occasionally; My left hand felt very cold; My left neck lymph node got tender and swollen; My left neck lymphnode got tender and swollen/ felt my lymph nodes in my neck and jaw somewhat swollen; Headache; Felt congested; This is a spontaneous report from a contactable consumer or other non hcp (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number, and Expiration date not reported), via an unspecified route of administration, administered in the left arm on 22Apr2021, as second dose, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 23Apr2021, the patient experienced my left neck lymph node got tender and swollen, my left neck lymph node got tender and swollen/felt my lymph nodes in my neck and jaw somewhat swollen. On an unspecified date in Apr2021, the patient experienced headache and felt congested. On an unspecified date in May2021, the patient experienced left hand was tingly/pins and needles/feeling lots of pins and needles in my left hand/tingling/ pins and needles in both hands and both legs/left foot and calf tingling, hand numbness and tingling was very intense, hand numbness and tingling was very intense to the point that it hurt, hand was tingly/pins and needles and kept me awake, left arm weakness/ some weakness in my legs, some loss of balance when walking occasionally, and my left hand felt very cold. Patient had 2nd Pfizer dose on 22Apr2021 in the left arm. Next day, patient's left neck lymph node got tender and swollen for few days. Few days later, patient had a headache and felt congested. During the first week, one night, patient's left hand was tingly/pins and needles and kept him/her awake. Then on 09May2021, he/she woke up with a headache and felt lymph nodes in neck and jaw somewhat swollen. He/She started feeling lots of pins and needles in left hand and some weakness in legs. Also felt some loss of balance when walking occasionally. Patient also noted his/her left hand felt very cold. Last night he/she woke up around 4AM with tingling/ pins and needles in both hands and both legs. They lasted until patient got up. Now, patient have tingling in left hand, left arm weakness and left foot and calf tingling. Patient was concerned about how these side effects are lasting. Patient stated he/she will make an appointment with a neurologist. Patient stated any insight would help. The outcome of all events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: queasy stomach; This is a spontaneous report received from a contactable consumer (patient). An adult female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on an unspecified date, (lot number was not reported), as unknown, single dose, for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included tofacitinib citrate (XELJANZ XR) taken for an unspecified indication, start and stop date were not reported. On an unspecified, the patient experienced queasy stomach and had health problems (unspecified, pending clarification). The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pyrexia, Vaccination site pain
Clinical narrative: Side headache; Fever; Slight Nausea; Soreness in injection site; This is a spontaneous report from a contactable consumer (patient) via a sales representative. A 25-year-old (reported as 20 - 30) female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number and expiry date unknown), via an unspecified route of administration on an unspecified date as second dose, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on an unspecified date. The patient experienced side headache, fever, slight nausea, and soreness in injection site after she got second dose of COVID-19 vaccine on an unspecified date. The outcome for the events was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Malaise, Pain, Pyrexia
Clinical narrative: general malaise; general weakness; fever; chills; body ache; This is a spontaneous report from a contactable consumer. A 50-year-old male patient received his second dose of BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: not reported), unspecified route of administration on 01May2021 as 2nd dose, single dose (at the age of 50 years old) for COVID-19 immunization. The patient's medical history includes hypertension but it is under control with medication (not mentioned). Concomitant medications included unspecified hypertension medication. Historical vaccine includes first dose of Pfizer COVID vaccine on 08Apr2021 (at the age of 50 years old), for COVID-19 immunization and no reported issues. On an unspecified date, while the reporter was playing cricket with his teammates against another team, he overheard the patient talking about general malaise and weakness. The patient also mentioned how he feels exactly how he felt after the 2nd shot of vaccine, which was the Pfizer COVID vaccine. The patient had body ache that night (01May2021) but took paracetamol (TYLENOL) and even played cricket the next day. On 03May2021, the patient had chills and fever, took paracetamol again and then no issues afterwards. On 12May2021, the patient had chills and general weakness but no fever and continued until 14May2021. On 15May2021, the patient was starting to feel better, no fever or chills but slight weakness. On an unspecified date, the patient experienced malaise. The reporter was not sure if the most recent malaise was vaccine related, but he figured he should err on the side of too much information. The outcome for general weakness was recovering; outcome for body ache, fever and chills was recovered on an unspecified date; outcome for malaise was unknown.   No follow-up attempts are needed. Information about lot/batch number can not be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Mild fever; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer (patient himself) reported that a male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number, and Expiration date not reported), via an unspecified route of administration on 15May2021, as second dose, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced mild fever on an unspecified date in May2021. Patient was having a mild fever and was wondering if he could take a pain reliever. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: patient was having allergies; This is a spontaneous report received from a Pfizer-sponsored program. A contactable consumer (parent) reported a male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on an unspecified date (batch/lot number: not reported) as 1st dose, single dose for COVID-19 immunisation. Patient's medical history and concomitant medications were not reported. On an unspecified date, it was reported that the patient was having allergies. The patient was scheduled to take the 2nd dose of BNT162B2 on the date of report. The reporter wanted to know what would be the recommendation for this situation. The reporter could not remember the exact date the patient received the 1st dose of BNT162B2 but said it was 3 weeks ago. The outcome of the reported event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Hypoaesthesia, Musculoskeletal stiffness, Paraesthesia, Sensory loss
Clinical narrative: tingling in his right pinky/tingling in certain parts of my legs saying "it'll flash then stop/Tingling in my fingers; My arm felt stiff; A loss of sensation stating "I really haven't had any sense of sharp pain; He states that the sensation is more warm or burning; that it was a "swelling/numbing effect".Swell little bit; I could feel things were swelling; He reports that immediately after he received the dose (in his right arm) he "could feel it throughout my body" and that it was a "swelling/numbing effect".; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 47-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection,Batch/Lot Number: ER8735), via an unspecified route of administration, administered in Arm Right on 12May2021 (Age at time of vaccination 47-years-old) as 1ST DOSE, SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. Patient stated that I took the Ibuprofen because when I first got the shot I could feel things were swelling (further details unknown), I could feel some like, I took pills at the time like a it was swelling like some pain initially and then I heard from other that to prevent the headaches and to prevent the soreness of the arm, to took Ibuprofen, so that I took it as a preventive measure that, I would not get sore but I didn't have any of those, my arm felt stiff but I never felt the pain, and I never feel any headache at the time, like I said, I kind of lost sense of acuteness, loratadine taken for hypersensitivity, start and stop date were not reported. Patient reports that immediately after he received the dose (12May2021) (in his right arm) he "could feel it throughout my body" and that it was a "swelling/numbing effect". He has since been experiencing neurologic symptoms that include:  tingling in his right pinky, a loss of sensation stating "I really haven't had any sense of sharp pain. I can feel pressure but can't determine actual point of pressure."  He also reports "tingling down [his] left arm while laying down last night" and tingling in certain parts of my legs saying "it'll flash then stop" and is most notable in the calf/shin of his right leg. He states that the sensation is more warm or burning, "not sharp pain" and that it will be a "small burst in a certain area, then go away". On an unknown date Patient also experienced that ,I kind of noticed that I can't feel thing I will say go numb as if kind of feeling through my body,Swell little bit; I could feel things were swelling,I don't have like feeling like touch like when I touch something I feel pressure but I don't have that huge sense of feeling,Tingling in my fingers, its practically I lost my left arm The  outcome of events was unknown.  Information on the lot/ batch number has been requested.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: tingling in his right pinky/tingling in certain parts of my legs saying "it'll flash then stop/Tingling in my fingers; My arm felt stiff; A loss of sensation stating "I really haven't had any sense of sharp pain; He states that the sensation is more warm or burning; that it was a "swelling/numbing effect".Swell little bit; I could feel things were swelling; He reports that immediately after he received the dose (in his right arm) he "could feel it throughout my body" and that it was a "swelling/numbing effect".; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 47-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection,Batch/Lot Number: ER8735), via an unspecified route of administration, administered in Arm Right on 12May2021 (Age at time of vaccination 47-years-old) as 1ST DOSE, SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. Patient stated that I took the Ibuprofen because when I first got the shot I could feel things were swelling (further details unknown), I could feel some like, I took pills at the time like a it was swelling like some pain initially and then I heard from other that to prevent the headaches and to prevent the soreness of the arm, to took Ibuprofen, so that I took it as a preventive measure that, I would not get sore but I didn't have any of those, my arm felt stiff but I never felt the pain, and I never feel any headache at the time, like I said, I kind of lost sense of acuteness, loratadine taken for hypersensitivity, start and stop date were not reported. Patient reports that immediately after he received the dose (12May2021) (in his right arm) he "could feel it throughout my body" and that it was a "swelling/numbing effect". He has since been experiencing neurologic symptoms that include:  tingling in his right pinky, a loss of sensation stating "I really haven't had any sense of sharp pain. I can feel pressure but can't determine actual point of pressure."  He also reports "tingling down [his] left arm while laying down last night" and tingling in certain parts of my legs saying "it'll flash then stop" and is most notable in the calf/shin of his right leg. He states that the sensation is more warm or burning, "not sharp pain" and that it will be a "small burst in a certain area, then go away". On an unknown date Patient also experienced that ,I kind of noticed that I can't feel thing I will say go numb as if kind of feeling through my body,Swell little bit; I could feel things were swelling,I don't have like feeling like touch like when I touch something I feel pressure but I don't have that huge sense of feeling,Tingling in my fingers, its practically I lost my left arm The  outcome of events was unknown.  Information on the lot/ batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Jugular vein distension
Clinical narrative: lump in her vein on the neck part; This is a spontaneous report received from a Pfizer sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number and expiry date unknown), via an unspecified route of administration on 12May2021 as second dose, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on 21Apr2021 for COVID-19 immunization. The patient reported that a lump in her vein on the neck part just appeared in the morning of 15May2021 with the outcome of unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: she is still feeling side effects and not well; This is a spontaneous report from a contactable consumer(patient) from a Pfizer sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number and expiration date were not reported), via unspecified route of administration on 13May2021 (reported as Thursday morning) as unknown, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in May2021, the patient experienced that she was still feeling side effects and not well. The outcome of the event was not recovered. The patient was querying if when she would be feeling back to normal.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain, Vomiting
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program. A contactable female consumer (patient's mother) reported that a 13-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number not available), via an unspecified route of administration on 16May2021 at 12:30 PM (at the age of 13 years old) as first dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced pain at the injection site, vomiting and feeling tired on 16May2021. The reporter said that her son's second dose was scheduled on June 6, 2021. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: By that day he felt a little chest pain; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer (patient himself) reported that a male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number, and Expiration date not reported), via an unspecified route of administration on 14May2021 , as second dose, single dose for COVID-19 immunisation. Medical history included blood pressure (hypertension), cholesterol, and gout. The patient reported he continues taking unspecified medications for his blood pressure, cholesterol, and gout, and he also took blood thinner. Patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number, and Expiration date not reported), via an unspecified route of administration on 23Apr2021, as first dose, single dose for COVID-19 immunisation. The patient experienced by that day he felt a little chest pain on an unspecified date in May2021. The outcome of event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Injection site pain; This is a spontaneous report from a contactable consumer (patient) A 42-years-old female not pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE ), dose 1 via an unspecified route of administration, administered in Arm Left on 03Feb2021 11:30 (Batch/Lot Number: 5318) as single dose or covid-19 immunisation  .  Medical history included crohn's disease from 1985 and ongoing (Father and brother have Crohn's disease)  The patient's concomitant medications were not reported.  The patient experienced injection site pain  (non-serious) on 03Feb2021 with outcome of recovered in feb2021. No treatment received for the event  Information about Lot/Batch number is obtained. Additional information has been requested
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Herpes zoster, Pain, Pruritus, Rash vesicular
Clinical narrative: Soreness and headache; Soreness and headache; Two clusters of blister rashes appeared 5 days after itch started along chest nerve line.; Not painful- assumed mild case of shingles.; Itchy back and right side of chest.; This is a spontaneous report from a contactable consumer (patient).   A 36-year-old non-pregnant female patient second dose of received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: ER8736), via an unspecified route of administration, administered in arm left on 03May2021 10:00 (at the age of 36 years old) as 2nd dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. No known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: ER8731), dose 1 via an unspecified route of administration, administered in Arm Left on 12Apr2021 10:00 as 1st dose, single dose for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within 2 weeks of vaccination. On 11May2021, the patient experienced itchiness on back and right side of chest. Not painful- assumed mild case of shingles. Followed by blister rash on 15May2021 in same places. Two clusters of blister rashes appeared 5 days after itch started along chest nerve line. All right side of body. Patient also had Soreness and headache. The treatment received for the not painful- assumed mild case of shingles, itchy back and right side of chest, two clusters of blister rashes appeared 5 days after itch started along chest nerve line was Clobetasol and valacyclovir. The patient underwent lab tests and procedures which included Nasal Swab PCR test: negative on 14Apr2021. The clinical outcome of the events not painful- assumed mild case of shingles, itchy back and right side of chest, two clusters of blister rashes appeared 5 days after itch started along chest nerve line was resolving and events soreness and headache was unknown.  Information on Lot/Batch number was available. Additional information has been requested.