chrisvoncsefalvay/vaers-outcomes huggingface dataset:
congested; feeling sick; This is a spontaneous report from a contactable pharmacist. This report was not related to a study or programme. A 68-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), dose 3 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. The reporter stated the patient did not provide any product information. Medical history included ongoing difficult for her to move up and down the stairs and ongoing psoriasis from an unknown date. The reporter explained the first thing the patient stated was she was waiting for a spinal fusion because it was difficult for her to move up and down the stairs. He stated it was unclear when this started. Concomitant medications included ongoing otrexup (METHOTREXATE) for psoriasis from an unknown date. She stated the Otrexup was working well. The patient previously received first and second doses of BNT162B2 on unspecified dates for covid-19 immunisation. Investigation assessment included none. The patient experienced congested and feeling sick on an unspecified date. The caller stated he was a pharmacist and Medical Information Specialist. Reporter had a call with a patient on the day of this report regarding one of their products. In the middle of the call, the patient and him talked about previous products she had used, and she mentioned two of Pfizer's products. The caller clarified he had an adverse event(s) to report for COVID-19 vaccine. Did not provide mailing address when probed. No further patient details were known. Full address unknown, but she was in (withheld). Patient added later in the call was that she was congested on the day of this report, she was feeling sick and didn't know why because she had booster of the COVID-19 vaccine three weeks ago. The caller stated she had the booster shot due to being on Otrexup. The patient did not specifically state any outcomes for the AEs mentioned. The reporter stated he had no further information to provide. Clinical outcome of events was unknown.  Information about lot/batch number will be obtained during follow-up.
Left arm began to hurt, get extremely red, and feel very warm later in the evening on day of vaccine. The redness began to cover a large portion of the arm. Patient came in Monday and reported discomfort and showed RPh the arm. Advised to continue icing arm and take oral analgesics. Called patient Tuesday morning and was informed it appeared a bit better but still bothered by it. Patient stated they had made MD visit for later in the day.
15-25min p/vax pt devel gen angiodema & erythema from neck down;no c/o SOB or wheezing;tx w/ 1cc 1:1000 epi subcutaneous & DPH;observed 30min;pt states similar rxn p/ 1st anthrax shot DEC98
Patients were administered the Moderna Covid 19 Monovalent booster instead of the bivalent; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patients were administered the Moderna Covid 19 Monovalent booster instead of the bivalent) and NO ADVERSE EVENT (No adverse event) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Patients were administered the Moderna Covid 19 Monovalent booster instead of the bivalent) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patients were administered the Moderna Covid 19 Monovalent booster instead of the bivalent) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patients were administered the Moderna Covid 19 Monovalent booster instead of the bivalent).    Concomitant medication information was not provided by the reporter.  It was stated that patient accidentally administered monovalent booster dose instead of bivalent dose.  Treatment information was not provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-650932, US-MODERNATX, INC.-MOD-2022-650934 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-650932:Same reporter US-MODERNATX, INC.-MOD-2022-650934:Same reporter
r/o allerg rash poss from immunization;fine erythematous rash on face & upper trunk
Information has been received from a physician concerning a 9 year old female who on 10-APR-2007 was vaccinated with Gardasil. On 11-APR-2007 the patient experienced a sore arm and nausea. This is one of two reports received from the same source. Additional information has been requested.
This spontaneous report was received from an approximately 60 year old female patient regarding herself. Current conditions included allergic reactions to amoxicillin (unspecified dose, frequencies and manufacturer) and many unspecified medications (unspecified names, dose, frequencies and manufacturer) make her sick to her stomach. There was no pertinent medical history. On 10-OCT-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot number and expiry date were reported as J004599 and 18-JUL-2014 respectively), subcutaneously. There were no concomitant medications. On 10-OCT-2013, after the vaccination, the patient experienced redness, swelling and a hard itchy lump at the injection site and itchy hives all over her body. The patient sought medical attention with her gynecologist on an unspecified date because her primary care doctor was not available. The Gynecologist prescribed prednisone (unspecified dose, frequency and manufacturer). No lab tests were performed. The patient was not recovered from redness, swelling and a hard itchy lump at the injection site and itchy hives all over her body. The relatedness for all the events was unknown for ZOSTAVAX. Additional information has been requested.
Patient stated that she ended up with welts that were itchy as well as overall itchiness. Pain at the injection site lasting 13 days after injection.
lost 7 pound; Lost appetite; has fluid in ears; feels hot; fatigue; Chills; Headache; A spontaneous report was received from a consumer concerning a 41-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events headache, chills, fatigue, feels hot, lost appetite, has fluid in ears, lost 7 pound.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 25 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 029L20A) intramuscularly for prophylaxis of COVID-19 infection. On 22 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 031L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 22 Feb 2021, the patient experienced the event(s) headache, chills, fatigue, feels hot, lost appetite, has fluid in ears. On 1 Mar 2021, the patient experienced the event(s) lost 7 pound.  Treatment details included prednisone.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), headache, chills, fatigue, feels hot, lost appetite, has fluid in ears, lost 7 pound was unknown.
Patient reported irritation and discomfort from injection site down to her fingers. Stated it started immediately after injection and has continued on where she has reached out to her doctor for treatment. She has tried medications (IBU, APAP, muscle relaxers) that have not touched or relieved the discomfort.
68 days after first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (68 days after first dose) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 16C21A) for COVID-19 vaccination.     NO Medical History Information was reported.    On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (68 days after first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (68 days after first dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant Concomitant medications were reported.   No Treatment information for the event was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Jun-2021 and was forwarded to Moderna on 04-Jun-2021.    This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (68 days after first dose) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 16C21A) for COVID-19 vaccination.     NO Medical History Information was reported.    On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (68 days after first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (68 days after first dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant Concomitant medications were reported.   No Treatment information for the event was provided.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 9:32 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 9:32 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 50.46  Concomitant products were not provided.  On 03-Apr-2021 Excursion time was reported at 09am with temperature as 34 degrees Fahrenheit respectively , total doses given for the day was 210 ,condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 30-Mar-2021, vial was moved to clinic on 03-Apr-2021. 20 vials were sent to clinic. Vaccine BUD date was 29-Apr-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Patient admitted to hospital 3/28/22 with SOB and cough. Some diarrhea is reported but no chest pain, vomiting, fever or chills.
dizziness beginning approximately four hours after injection lasting about two hours; fatigue lasting two days after injection; severe pain in the arm beginning immediately after injection lasting several weeks (strong enough to interfere with ability to sleep)
sharp pain on the bottom of his foot said it feels like he stepped on a nail; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sharp pain on the bottom of his foot said it feels like he stepped on a nail".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
site soreness; nasal stuffiness; difficulty breathing; throat began closing up; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient (also reported as age at vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL8982), via an unspecified route of administration on 14Jan2021 at 12:00 at a single dose on the left arm for COVID-19 immunization. Medical history included two recent right shoulder surgeries. Concomitant medication included oxaprozin. The patient previously took oxycontin and experienced allergies and an unspecified allergy shot last 06Jan2021 on the left & right arm. The patient was not diagnosed with COVID-19 prior to vaccination. On 15Jan2021 at 01:30, the patient was having difficulty breathing and throat began closing up. Patient's wife was going to call 911 but after about an hour, incident appeared to be getting better. On the next day (16Jan2021), the patient felt better with minor site soreness and nasal stuffiness. The patient did not receive any treatment for the events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering.
Hives on posterior thighs: multiple itching excavated papules. On anterior thighs erythroderma patches and pretibular areas similar patches mod edema knees. I noted areas pretibial above ankles.
Swelling, erythema, blisters, pruritus around site of injection. Pt took Advil to some avail.
pain in left knee, moved to left anle, then throughout  body (one area at a time, not cumulative) Narrative:  Pt followed up with PCP for evaluation of  arthralgias
Since last night nauseous; Since last night bad headache which I never have; Since last night light fever; Flu like feeling; Shooting pains everywhere have arthritis; Clammy; Tingling in head all on & off last 5 days; Last five days extreme tiredness; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: E128733) via an unspecified route of administration in the left arm on 06Apr2021 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included arthritis and Barrett's esophagus. Concomitant medications included gabapentin (MANUFACTURER UNKNOWN), omeprazole and clindamycin (MANUFACTURER UNKNOWN) all started from an unknown date, for unknown indication and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207) via an unspecified route of administration in the left arm on 16Mar2021 at 07:45 as a single dose for COVID-19 immunisation. The patient previously received codeine (MANUFACTURER UNKNOWN) which caused allergy. 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 did not receive any other vaccines within four weeks prior to the COVID vaccine. It was reported that, from last five days, 06Apr2021 at 12:00, the patient experienced extreme tiredness, clammy, flu like feeling, shooting pains everywhere have arthritis, tingling in head all on and off last 5 days. Since last night, on 10Apr2021, the patient felt nauseous, bad headache (which she never had) and slight fever. The patient had been taking TYLENOL every 6 hours as therapeutic measures for the reported events and reported to first time having to take something but not helping. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events flu like feeling, shooting pains everywhere, clammy, tingling in head, extreme tiredness, nauseous, bad headache and slight fever was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
I have a five inch by five inch red, swollen injection site reaction.  That lasted from 1/1/21 to 1/8/21.  As of today, it is a faint 5 X 5 injections site pink reaction.  I also am still occasionally getting zapping pain that feels like a needle. The pain was bad the night of the injection until 1/7/21.  I took 800 MG of Ibuprofen every 6 hours. I also could not use my left arm due to the pain and inflammation from 1/1/21 to 1/3/21. When I rolled over on it at night, it would wake me up. I also the first four days, felt tired, and unwell.  I called the pharmacy and was told my reaction was normal.  Therefore, I did not call my GP doctor.
Took NSAID (ibuprofen) to relieve pain and reduce fever. Applied local analgesic to injection site (Methyl/M-salicylate, camphor, menthol ointment).
Severe abdominal, kidney, liver, uterus, ovary pain, difficulty breathing, severe chest pain and tightness, coughing, increases heart rate, decrease in oxygen levels (verified by oximeter), dizziness, confusion.
This is a spontaneous report from a contactable other hcp (nurse) via medical information team. A female patient of an unspecified age received third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: not reported), dose 3 via an unspecified route of administration, administered in arm on 12Oct2021 as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously received second dose of Covid-19 vaccine (manufacture unknown) dose 2 via unspecified route of administration on an unspecified date and received Covid-19 vaccine (manufacture unknown) dose 1 via unspecified route of administration on an unspecified date for Covid-19 immunisation. Nurse said they had undiluted vials of the Pfizer-BioNTech Covid-19 Vaccine that were already taken out and shipped to them. She said they were told to use the vaccines until 01Oct2021. However, the vaccines were stored inside the refrigerator for more than 31 days. She said 11 of these vaccines were given to patients. 1 was given as a first dose on 6Oct2021, and the rest were given as booster doses yesterday, 12Oct2021. HCP wants to know if they need to revaccinate the patients. Caller said she had information for the first six patients to provide, but she doesn't have full information for the rest and would have to look those up. Caller said she doesn't have patient's numbers, and doesn't have which arm was given for those last five patients. She says she does have the NDC/LOT/EXP and the date given for those, which for those patients the third dose booster dose was given 06Oct2021. Caller says she doesn't have provider information for the patients other than the for the first patient.    The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up. Linked Report(s): US-PFIZER INC-202101368445 same reporter/drug/event, different patient.
Person indicated that they felt lethargic and had a headache.; Person indicated that they felt lethargic and had a headache.; This is a spontaneous report from a non-contactable consumer (patient). A 34-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, number: EC0142), via an unspecified route of administration on 20Jan2021 at single dose in arm left for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not have COVID prior vaccination. The patient previously received the first dose of BNT162B2 (lot number: EC 1284) in Left arm on 30Dec2020 for COVID-19 immunisation. The patient indicated that they felt lethargic and had a headache on 21Jan2021. The patient was not pregnant at the time of vaccination. COVID was not tested post vaccination. There was no treatment received for the event. Patient was recovered on an unspecified date in Jan2021.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a healthcare worker refers to a male patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. The patient had completed both VAQTA (dose, lot# and route not reported) and RECOMBIVAX HB (dose, lot# and route not reported) series on an unspecified date. On 08-APR-2015, the patient was inadvertently vaccinated with an extra dose of both VAQTA, (dose, lot#, expiration date, route and injection site were not reported) and RECOMBIVAX HB, (dose, lot#, expiration date, route and injection site were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
I had severe arm pain at injection site an hour after vaccine. I began having chills, body aches, joint pain, back pain, headache, dizziness and a light fever of 99 at approximately 4:45pm on 1/29/21. Its currently 10:25pm and I am still having these symptoms even with taking two ibuprofen pills every 4-6 hours and consuming electrolytes.
hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced URTICARIA (hives). At the time of the report, URTICARIA (hives) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Customer felt fully numbed in the injected arm and need Dr's visit. Dr prescribed naproxen 550mg and TYLENOL #3.
Extreme pain and inability to lift with arm of injection. Pain is less after 2 days bu the are of injection is red and slightly swollen, very tender to the touch in a radius of about 4 by 4 inches.