chrisvoncsefalvay/vaers-outcomes huggingface dataset:
equilibrium went out; couldn't stand up; fell; muscle pain; low grade fever, it was like 100; headache that just won't quit; This is a spontaneous report received from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 09Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had first Pfizer shot on the 9th and Sunday (11Apr2021) satin come to visit, patient equilibrium went out. Patient couldn't stand up, fell. Patient had muscle pain and had a very low grade fever, it was like 100. The injection site was fine but patient had a headache that just won't quit. Patient wanted to known what should take to get rid of this headache. The outcome of the event headache was not recovered and the outcome of the other events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
delayed redness on both arms and upper hip; a little swollen; kinda itchy; rash on arm, torso and legs to ackles /hip/  both arms; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on arm, torso and legs to ackles /hip/  both arms), ERYTHEMA (delayed redness on both arms and upper hip), SWELLING (a little swollen) and PRURITUS (kinda itchy) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No Medical history was provided by the reporter.     On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced RASH (rash on arm, torso and legs to ackles /hip/  both arms). On 26-Mar-2021, the patient experienced ERYTHEMA (delayed redness on both arms and upper hip), SWELLING (a little swollen) and PRURITUS (kinda itchy). The patient was treated with HYDROCORTISONE for Adverse event, at an unspecified dose and frequency and BETAMETHASONE DIPROPIONATE for Adverse event, at an unspecified dose and frequency. At the time of the report, RASH (rash on arm, torso and legs to ackles /hip/  both arms), ERYTHEMA (delayed redness on both arms and upper hip), SWELLING (a little swollen) and PRURITUS (kinda itchy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.     Caller received the first vaccine a month ago.  After the first week after the vaccine, caller said she experienced a rash on arm and on upper hip.  Caller said she went to dermatologist.  Caller said dermatologist advised to get the second dose.  Caller said she spoke to a doctor who said that people had this rash.  Caller got her first dose on 24mar21, LOT#018B21A.  Caller said doctor gave her betamethasone dipropionat 0.05 cream, and it was very effective. Caller said she had redness, a little swollen, kinda itchy.  Caller had it on both arms and above the hip.  Caller said she did not get the second dose when she was suppose to but she plans on getting the second dose after talking to moderna.  Caller wanted to know if she should get second dose and whether she will get the rash again.   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Follow up appended on 30-April-2021 Added events & events outcome and Treatment details
Information has been received from a health professional concerning a 7 year old female who on 09-AUG-2007 was vaccinated subcutaneously in the right thigh with VARIVAX (Oka/Merck) (Lot # 657757/0641U).  Concomitant therapy included Hep A (unspecified).  On 10-AUG-2007 the patient experienced injection site induration.  It was reported that the patient had a "12cm x 13 cm area "erythroneia" center area with firm, tender warm induration" on her right lateral thigh.  The patient was treated with KEFLEX.  The patient outcome was not reported.  The reporter considered injection site induration to be an other important medical event.  Additional information has been requested.
Narrative: Patient vaccinated in March 2021 developed a breakthrough infection in Oct. 2021. The patient is high risk for complications due to age and comorbid conditions. He will be treated with monoclonal antibodies.
Pt recvd vax 6JUN92 mom returned w/pt on 8JUN92 w/knot (quarter size) in rt leg in area of DTP inject; pt was not fussy or running temp, moving leg normally; will return in 1 wk if knot still present;
This spontaneous report was received from an office manager, and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies was provided. On 26-MAR-2018, the patient was vaccinated with an improperly stored dose of ROTATEQ, orally, (lot # N013992 with an expiration date in 27-JAN-2019), for prophylaxis, (dose and frequency were not provided), that underwent multiples temperature excursions with a temperature below of 32 degrees Fahrenheit, during an unknown time frame. Digital data logger was involved. No adverse effects were reported. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1804USA003815; US-009507513-1804USA003816; US-009507513-1804USA003817; US-009507513-1804USA003818; US-009507513-1804USA003819; US-009507513-1804USA003820; US-009507513-1804USA003821; US-009507513-1804USA003823; US-009507513-1804USA003824; US-009507513-1804USA003769.
lack of efficacy- fully vaccinated with CV19 + via PCR on 15Sep2021.; lack of efficacy- fully vaccinated with CV19 + via PCR on 15Sep2021.; This is a spontaneous report from a contactable other healthcare professional. A 32-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), via intramuscular route, administered in arm left on 08Apr2021 (Lot Number ER8729 and expiry date was not reported, at the age of 31-year-old) as single dose and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), via intramuscular route, administered in arm left on 29Apr2021 (Lot Number ER8736 and expiry date was not reported, at the age of 32-year-old) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown whether the patient was diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had been tested for COVID-19. On 13Sep2021, the patient underwent COVID test post vaccination, PCR (Nasal Swab) which was positive. It was unknown if patient received treatment for AE. It was reported lack of efficacy- fully vaccinated with CV19 + via PCR event reported on 15Sep2021. Device Date was 16Sep2021. Outcome of the event was recovering.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the temporal relationship the causal role between the events Vaccination failure and SARS-CoV-2 test positive cannot be fully excluded. However the possibility of Covid being an intercurrent condition cannot be ruled out.
Patient experienced full body chills approximately 5 minutes following vaccine administration. Approximately 10-15 minutes are administration, patient began to experience weakness, "heaviness" in bilateral legs, hypertension (152/98), tachycardia (112 bpm), and lightheadedness. Approximately 30 minutes after vaccination, patient was evaluated by MD  and noted to be wheezing.  Patient given albuterol nebulizer and 25 mg  of Diphenhydramine. Wheezing resolved. Patient was sent home by MD.   02/11/2022- Patient contacted MD regarding continued symptoms. She was prescribed Prednisone and given Albuterol inhaler.   02/14/2022- Patient returned to clinic and was evaluated by FNP. Patient reported chest pain/pressure, tachycardia, continued hypertension, and continued weakness. She had negative chest xray and negative d-dimer. Patient was sent home by FNP.
Hi fever of 104,  chills, muscle achiness, severe reaction at site of injection (very red and swollen)
Starting 3/11 Left arm with warmth, itch and redness.  Onset of headache and fever 3/11 in afternoon
Tinnitus 5 days after receiving 2nd vaccine.  First in right ear, next day left ear.  Went to ENT specialist.
This spontaneous report was received from a registered nurse and refers to a 4 year old female patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 05-OCT-2016, the patient was vaccinated with an improperly stored dose of VARIVAX, lot # reported as M010476 with expiration date of 01-SEP-2017 (dose, route and frequency were not reported) for prophylaxis. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 8 days. It was reported that there was no need to repeat vaccine. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1705USA014053:
CHILD RCVD INFANT FORMULATION (6M-4Y) AT 5YO. PER VACCINE AGE INDICATION CHILD SHOULD'VE RCVD 5Y-11Y FORMULATION.
This spontaneous report as received from a certified medical assistant, via a company representative, refers to a male patient of unknown age. No information on his medical history, concurrent conditions or concomitant drugs was provided. On an unknown date the patient was vaccinated with a dose of PNEUMOVAX 23 dose, site and route of injection, lot# and expiration date not reported. On an unknown date, after receiving PNEUMOVAX 23, the patient developed a high fever. The patient sought medical attention and visited an unspecified Emergency Room for treatment, but it was unspecified whether was admitted or not. The outcome of the adverse was unknown. Relatedness between use of PNEUMOVAX 23 and the high fever was not reported. Additional information has been requested.
I21.19 ACUTE ST ELEVATION MI, INFERIOR WALL 4/4/2023 ACUTE ST ELEVATION MI, INFERIOR WALL
Serious fatigue  Dizzy spell where i couldn't Stand for too long. Lasted a day
This is a spontaneous report from a contactable consumer. An adult female patient of unspecified age received PREVNAR single dose via an unspecified route of administration. Relevant medical history and concomitant medications were not reported. The patient experienced unusual swelling at the site of injection and knot in her arm, swelling at the site on an unspecified date with outcome of not recovered. The consumer reported that the patient had been putting ice on the site. Follow-up (20MAY2015): Follow-up attempts completed. No further information expected.
Feb 17 - second pfizer shot. Shortly after second dose, was instructed to stop warfarin (for h/o VTE, pt with IVC filter) March 3rd - ultrasound of legs both clear  ~April 27th - c/o leg pain May 6 - admitted to hospital with DVT, PE
Vaccine site is itchy, hot to the touch, painful. Adverse reaction started last night (4/2/2021)
First night, itching. Next night, itching and hives developed.  One morning I experienced wheezing, but only one time.  Itching and hives continues now as of 06/10/2003.  Went into Dr.'s office today, Prednisone 10mg was prescribed.
2 weeks after the vaccine, he has an injection site irritation.  The arm is red, swollen, and warm to the touch.
Right leg swollen, moderate edema, erythema marked with central purpura, pruritis, tender, very hot, extending from thigh to knee.
she was exhausted and she laid down; arm was sore; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "she was exhausted and she laid down"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm was sore".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
The site of the vaccine started getting red and warm.  By 2:30 pm day after vaccine I started getting chills, headache, nausia.  Went home and had consistent sweats.  Took two doses of tylenol at the recommended intervals.  Went to work the next day symptoms again started in the later afternoon.  Took tylenol.  What is most noted is the site of vaccine.  The redness and swelling continues to grow in size.  It is hard, red and the size of a soft ball.  I work in a medical setting and was told to use ice.  The swelling is less but the redness continues to expand.   Interestingly, my arm does not hurt.  Day three, my symptoms remain decreasing except for the redness , warmth and diameter of the redness.  I felt it was important to add to the information.  People at work (RNs ) have not seen a vaccine site this red, hard and warm to touch.
Patient received vaccine on 07/31/19 and came in on 08/02/2019 with a slight bruise on her arm and a red spot (looked similar to cellulitis) about 3-4 inches away from the injection site.  She complained that it was painful and sensitive to touch.  The size of the area was about the size of a 50 cent piece.
Cutaneous inflammation around injection site. I noticed it the morning after the injection, it is slightly less inflamed today (3 days after) but still very noticeable. Affected area is red, raised and firmer than surrounding unaffected tissue. I have treated with ice. Discomfort is fairly minor.
Following shot #2 of Moderna Covid-19 vaccination, Pt experienced GI issues that lead to an ER visit followed by colonoscopy with DX of Severe pan-colitis c/w indeterminate colitis
Joint pain, body warmth, pain at site of vaccination, Third day ( today), sore throat, continued body aches, increased fatigue.
Information has been received from a registered nurse concerning an 82 year old male oncology patient, who on Dec 20 2004 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 649988/0692P). On Dec 23 2004, the patient experienced pain, redness and swelling from the injection site to the elbow. The patient was treated with antibiotics. The patients outcome was unknown. Unspecified medical attention was sought, No product quality complaint was involved. The reporter expressed a concern would with lot 0692P. It was also reported that tow other patients were vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 649988/0692P) and experienced adverse events (WAES0412USA02891, WAES0501USA00661). The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory, The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
5 minutes after nasal mist "throat feels like something needs to be cleared out." Had drink of H2O, vitals done.  Discharged per MD.
Mother noticed rash on trunk/back 1/25/16. Flu shot given 1/20/16. Rash worsened since 1/25/16.
Eight days after the first vaccine was administered, a red circle developed around the injection site on my left arm. The injection site also itched. The red circle is still present on my arm as of March 3rd and itches occasionally.
Small spots at the injection site; Hardness at the injection site; Injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE DISCOLOURATION (Small spots at the injection site), VACCINATION SITE INDURATION (Hardness at the injection site) and VACCINATION SITE PAIN (Injection site pain) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE DISCOLOURATION (Small spots at the injection site), VACCINATION SITE INDURATION (Hardness at the injection site) and VACCINATION SITE PAIN (Injection site pain). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, INJECTION SITE DISCOLOURATION (Small spots at the injection site), VACCINATION SITE INDURATION (Hardness at the injection site) and VACCINATION SITE PAIN (Injection site pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was reported   This case was linked to MOD21-027217 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: received on 22-APR-2021 and does not contain any new information; Sender's Comments:  MOD21-027217:
Severe chills, weak limbs, stroke-like weakness. Admitted to the hospital, stabilized. Discharged 9/29/17.
This case was reported by a consumer (subject's mother) and described the occurrence of injection site cellulitis in a 25-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. The subject's medical history included ear infection treated with antibiotics and rash due to antibiotics. Concurrent vaccination included DTPA vaccine (non-GSK, Sanofi Pasteur) given on an unspecified date when he was 22 months old. On 22 April 2014, the subject received unspecified dose of PEDIARIX (unknown route, left thigh). On 23 April 2014, 1 day after vaccination with PEDIARIX, the subject experienced jerking, twitching and tremor in sleep. On 24 April 2014, the subject experienced hardness and redness at injection site and severe constipation. The child was breast fed on demand and had never experienced constipation before. The injection site reaction was diagnosed as cellulitis. This case was assessed as medically serious by GSK. The subject was treated with Magnesium and constipation improved. At the time of reporting, the injection site cellulitis was resolved but the shaking, twitching and jerking were unresolved. The subject was referred to a neurologist.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Nov2022 at 10:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 76 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: Treatment for Asthma and Congestion; "known allergies: penicillin" (unspecified if ongoing), notes: known allergies: penicillin; "Preservative Sulfites" (unspecified if ongoing), notes: known allergies Preservative Sulfites, metabisulfites; "known allergies: NSAIDs" (unspecified if ongoing), notes: known allergies: NSAIDs; "Congestion" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Aspirin, reaction(s): "known allergies: aspirin", notes: known allergies: aspirin; Saccharin, reaction(s): "known allergies: saccharin", notes: known allergies: saccharin.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: Treatment of COVID-19. The patient received Paxlovid on 29Dec2022 to 02Jan2023 as treatment of COVID-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
covid-19; covid-19; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A 53-year-old male patient received BNT162b2 (BNT162B2), on 19Jan2021 as dose 1, single (Lot number: EL3248) and on 09Feb2021 as dose 2, single (Lot number: EL3248) at the age of 52 years intramuscular for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Known allergies: yes, reaction(s): "Allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 17Jun2022, outcome "unknown" and all described as "covid-19". The event "covid-19" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Jun2022) Positive, notes: Nasal Swab. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: If other vaccine in four weeks was reported as No. Other medications in two weeks was reported as No treatment Paxlovid. If covid prior vaccination was reported as no. If covid tested post vaccination as reported as yes.  No follow-up attempts are possible. No further information is expected.
At around 2000 23Apr08 I started to become nauseous with throbbing leg, back hip, and stomach pain. At around 2130 I began to burn a fever. I had the fever all night with loss of sleep.
1. change in mental activity - felt like thoughts slowed down (felt almost similar to the effects of marijuana); lost all focus/concentration; felt abnormally calm and slow (04/20/2021 - 4:00 pm - 5:30 pm)   2. fever, body shakes, nausea,  body pain, and pain in injected (left) arm (04/20/21 11:30 pm - 04/21/21 11:00 am) 3. vomiting (04/21/2021  12:30 am - 4:00 am)  4. brain fog  (04/22/2021 7:00 am - 5:20 pm)
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 023C22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date).    This case belongs to 3 of 20 patients described by the reporter.  No concomitant and treatment medications were reported.  20 Patients received Spikevax past the 30 day expiration date. No Other information was available at this time. Pharmacist provides permission for Safety to contact him via e-mail.