chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received Covid vaccine on 1/31/20 at 10:15 am. Went to bed. Woke at 3:00 am with both feet and calves ached. The pain decreased throughout the day. On 1/2/21, my right foot and leg were fine and pain has not returned since then. My left foot, ankle, and shin hurt pain level 2 of 10 on and off all day. Same on 1/3/21. On 1/4/21 the left leg, ankle, and foot hurt 7 of 10. Same on 15/2021. The pain seems to be moving upwards, almost to my knee at times. The pain is usually an ache all over the left food, ankle, shin. Sometimes I get sharp jabs of pain while sitting or walking. Aleve sometimes helps. Heat pad made it worse. Cold pad made it a little better.
Covid arm, red rash spread over arm, was itchy, but now it only heards and has spread a bit more.
At site of injection there is an induration, warm to touch & tenderness of an area of 5x10 cm - (L) arm - Prescribed ZYRTEC.
similar reaction hives the whales/the welts; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): MOD-2023-710892 (RA).  An adult patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: URTICARIA (non-serious), outcome "unknown", described as "similar reaction hives the whales/the welts". Therapeutic measures were taken as a result of urticaria. Additional information: There were a total of 12 patients on a study based on 7 from Pfizer and 5 from Moderna that had similar reaction hives the whales. And that they proceeded to get another vaccine. In some cases had another similar reaction where they had the hives, the welts. But at the time when they had them they took an antihistamine and it relieved it. It was just resolved simply by taking an antihistamine. The hives reappeared. They didn't have any respiratory problems. They didn't have any cardiac problems.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300033836 Same reporter, same drug, same event, different patient;
Pfizer 3/19/21, 4/18/21, 11/13/21. Positive on 1/23/23
Patient reported fast heartbeat, sweating.  Patient was pale, HR 112, O2Sat 96%, BP 108/60, reported feeling dizzy, vision changes, had brief moment of syncope, then aroused,  Oxygen applied at 2l via NC, patient continued with sweating, HR now 78, EMS called, patient continued with sweating and feeling weak gradual improvement, EMS arrived, patient evaluated and did not want to go to ER for eval.  Vitals rechecked and patient ambulated to private vehicle with no further difficulty.
Itchy uncomfortable red rash around neck, arms, breasts, armpits, under breast/ chest area, stomach , slowly spreading past torso to legs.
5:58 pt. held by mother, vaccine admin. IM in RD. Pt then goes to front of office. 6:00 upon returning, pt collapses in hallway. Pt is unresponsive. Pt opens her eyes after 1 min of verbal/physical stimulation. Pt is unable to speak for follow commands and extremities remain flaccid. Pt is pale, HR thready. Pt is taken to ER per mother's request and monitored there then discharged to home. 10/31/13 8:30 mother is called and reports is low grade temp and general malaise.
sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "sick".  Additional information: It was reported that after spending the last year and a half (from the day of this report) being sick from the Pfizer vaccine, the patient ignored everything she saw related to the vaccines. Age of the patient was also reported as 43 (units not provided).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Vaccine administered on 4/26/07.  Developed left arm swelling, redness and tenderness.  4/28/07 visited ER for increasing redness, swelling and tenderness.  No fever, no resp. distress.  Given Clindamycin and discharged with dx of cellulitis.  Returned to ER 4/29/07 with whole body rash, pedal edema, increased left arm swelling, urticaria.  Rash was macular, warm, tender, and erythematous.  No resp. distress, no mucosal lesions.  Given Benadryl and 2 mg/kg of Orapred.
No adverse event; Administration of improperly stored ROTATEQ; This spontaneous report was received from a medical assistant and referred to a patient of unknown age and gender. There was no information about the patient's pertinent medical history, drug reactions, allergies, and concomitant medications.   On 21-DEC-2021, the patient was vaccinated with an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 2 milliliters (ml), route defaulted to oral, lot # 1741817, expiration date: 30-JUL-2022, (route of administration and anatomical location were not provided), for prophylaxis. (Product storage error). The administered dose of vaccine experienced temperature excursion of 50.5 degrees Fahrenheit for 57 minutes. There was no previous temperature excursion reported.     No product quality complaint (PQC) and no additional adverse event (AEs) were reported.
Within 3 days the skin on my palms and bottom of my feet started to peel off in thick sheets. There was not pain other than the underlying skin was tender. I have never had any peeling of skin in either location. There was some mild fatigue the day after the injection.
Large 15 cm x 18 cm wheal on left arm, swollen, warm to touch, indurated, non-tender.
Patient returned 10-19-10 the day after receiving vaccine, he reported sore arm and no redness or swelling at injection site. Counseled him to watch for swelling/redness at injection site and inform us how he was progressing. Patient called his clinic after injection site irritation got worse. Patient went to Emergency Room 10-21-10. Antibiotics and pain medication prescribed, possible cellulitis diagnosed. 10-28-10 patient contacted and he reported symptom improvement.
This spontaneous report as received from a health worker refers to a 59 year old female patient with allergy to tetracycline. On 18-FEB-2013, the patient was vaccinated with ZOSTAVAX 1 vial for via intramuscular route instead of subcutaneous route (lot # H019034, expiration date: 17-JAN-2014). In February 2013, the patient developed an ulcer at the injection site after receiving a dose of ZOSTAVAX. The patient sought medical attention in the hospital. On 21-FEB-2013(approximately) the patient was admitted at the hospital. The patient outcome was not provided. Additional information has been requested.
The covid vaccine intended for 5-11 yr old was given in error to this patient.; no adverse effects
- bitter taste in back of mouth immediately upon receiving vaccine for all 3 occurrences. Lasts roughly 10 minutes, at the most.   - Red, raised, hard, itchy swelling at injection site beginning roughly 2 days after 12/2/2021 booster injection only.   - from 12/4/2021 - 12/6/2021 red rash has tripled in size, is still itchy, raised and hard. Occurred after 12/2/2021 booster injection only.
Dec 2021 left arm in the night got real tight like a pressure cup believe i was having a stroke Jan 2022 fell ill with high fever Apr 2022 fell ill with high fever May 2022 fell ill ill with high fever Jun 28, 2022 fell ill with high fever Jul 26, 2022 fell ill with 102.8 fever
Information has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medication were not reported. On an unspecified date, the patient was vaccinated with an improperly stored dose of PROQUAD, lot number N019250 with expiration date in 20-DEC-2018 (strength, anatomical location, dose number and route of administration were not provided), for prophylaxis. A properly stored sterile water diluent (DILUENT MRK) (lot number and expiration date were not provided) was used to reconstitute the vaccine. The vaccine was exposure to a temperature excursion; the data logger registered a temperature range between 15 degrees Fahrenheit (°F) to 46 °F for the time frame of 20 minutes. There was no previous temperature excursion. No adverse effects were reported.
The day after receiving the shot, I noticed bruising at site of needle entry and a hard, painful, swollen red area 3-5 inches below  the injection site.  On day 8, the bruising is still present and although the hard, painful, swollen red area had subsided by days 5-7, the hard, painful, swollen red area is back and it is now also itchy.    In addition, I had a mild headache the afternoon, evening after receiving the shot, and I had breast soreness and occasional pain the day after the shot and although this has also subsided, my chronic costochondritis has been irritated.
Pt. fainted 5 mins after receiving MENACTRA vaccine. Felt dizzy, no Loc. Had pt. laying down for 5 min with feet elevated. Then moved to a room and monitored.
pt recvd vax 12AUg93 mom states cried constantly until approx 7PM; called MD who said inc APAP & observe; fever never over 101 slept p/crying stopped & felt ok next morning;
Herpes zoster. Likely related to the Varviax vaccine received 2 months earlier. Patient did not have chicken pox and had no contact with anyone who had it.
Chicken pox - mild - onset 1/16/00, 2 wks post exposure <10 sesions only.
Discomfort at injection site; Dry skin; Rash on both legs, then traveling to buttocks, torso, and underarms; This case was reported by a physician via call center representative and described the occurrence of injection site discomfort in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th March 2019, the patient received the 1st dose of Shingrix. On 31st March 2019, 3 days after receiving Shingrix, the patient experienced widespread rash. In April 2019, the patient experienced injection site discomfort and dry skin. On an unknown date, the outcome of the injection site discomfort was unknown and the outcome of the widespread rash and dry skin were not recovered/not resolved.   It was unknown if the reporter considered the injection site discomfort, widespread rash and dry skin to be related to Shingrix.  Additional details were provided as follows: The reporter stated that, the patient experienced discomfort at injection site following dose 1 of Shingrix series. Three days later the patient experienced a rash on both legs. On 9th April 2019, the patient sought treatment from dermatologist for rash. The healthcare professional described rash as starting on both legs, then traveling to buttocks, torso and underarms. The reporter stated that the patient still has dry skin. The healthcare professional did not have lot number and expiration date for provider.
patient stated has redness and swelling in left arm accompanied by a fever and back ache on 7/23, stated that fever had resolved and back ache was better on 7/24 than on 7/23, redness in arm was slightly better.
CHILLS; HEADACHE; MUSCLE ACHE; LOW GRADE FEVER BELOW 100F; This spontaneous report received from a patient via a company representative concerned a 48 year old male. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: CA3A21A, and  expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 12:15 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, Laboratory data included: Body temperature (NR: not provided) 100 F. On 07-APR-2021 20:00, the subject experienced headache. On 07-APR-2021 20:00, the subject experienced muscle ache. On 07-APR-2021 20:00, the subject experienced low grade fever below 100f. On 07-APR-2021 20:00, the subject experienced chills. Treatment medications included: paracetamol. On 08-APR-2021 12:00, treatment medications included: paracetamol. On 08-APR-2021 16:00, treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, muscle ache, low grade fever below 100f, and chills on 09-APR-2021. This report was non-serious.
BODY ACHE; CHEST PAIN; ANXIETY; 88 BPM HEART RATE; BODY CHILLS; MUSCLE ACHE; FEVER 102; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 21-JUN-2021 16:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 21-JUN-2021, the subject experienced body ache. On 21-JUN-2021, the subject experienced chest pain. On 21-JUN-2021, the subject experienced anxiety. On 21-JUN-2021, the subject experienced 88 bpm heart rate. On 21-JUN-2021, the subject experienced body chills. On 21-JUN-2021, the subject experienced muscle ache. On 21-JUN-2021, the subject experienced fever 102. Laboratory data included: Body temperature (NR: not provided) fever 102, and Heart rate (NR: not provided) 88 BPM heart rate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever 102, body ache, chest pain, anxiety, 88 bpm heart rate, body chills and muscle ache was not reported. This report was non-serious.
This spontaneous report was received from a nurse referring to a patient of unreported age and gender. The patient's pertinent medical history, concomitant therapies, and previous drug reactions or allergies were not reported.  On 15-DEC-2021, the patient was vaccinated with expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II), subcutaneous (SQ), 0.5 ml (milliliter) for prophylaxis (expired product administered) (lot number S039309 has been verified to be a valid lot number, the expiration date was reported and established as 31-MAR-2018; dose number, vaccination scheme and anatomical site of vaccination were not reported).   No additional AE was reported.
Scattered papules on bilat ant thighs, around presumptive sites of vax admin.
Shortley afer vaccination patient started experiencing dizziness and was seated with parent on her lap. Her lips were discolored But no difficulty in breathing or swelling of Lips, etc. Called 911 for precautions, Learned patient had not eaten a full meal since lunch. Paramedics Arrived - Monitored & left with parents.
Sore bicep/tricep muscle in arm with injection site.  2 inch rash on bicep 3 inches below injection site.
Information has been received from a nurse concerning a 19 year old female who was vaccinated with all three doses of GARDASIL (lot# dose 1, 654389/0961F, dose 2, 657617/0384U, dose 3, 658094/0524U). The nurse stated that prior to receiving GARDASIL the patient's PAP test results were normal. However, following the completion of the series the patient received another PAP test which showed "High-Risk HPV positive". The nurse also stated that the patient tolerated all of three doses well. It was unknown whether medical attention was sought. The patient's outcome was unknown. Additional information has been requested.
Information has been received from a nurse concerning multiple unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored GARDASIL (lot # K011325 with expiration date 08-APR-2017 and lot # L040459 with expiration date 06-APR-2017, dose and route unspecified), which was exposed to temperature excursion 30 Fahrenheit degree (F) for 10 total cumulative hours. It was reported that there was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Patient complained of facial flushing. Denies respiratory distress, is A& O x 4, V/S are: 1st attempt at 11:20 AM: BP 176/78; P-88; RR 20, 2nd attempt at 11:32 AM: BP 130/72; P-82; RR-18.  Patient offered monitoring for 1 hour, refused ,patient was stable, reports minimized facial flushing, no respiratory distress reported. Patient encourage to go to the ER if having any trouble breathing, verbalized understanding.
Narrative:  COVID infection following COVID vaccine series 12/30/2021, Pfizer, dose #1 01/19/2021 Pfizer, dose #2 08/15 pt cc: cough, fatigue, loss of taste or smell, rhinorrhea, exposure: friend 08/27 COVID swab, result: detected
Patient was injected with Moderna 0.5mg approximately 5:20. She reported, perioral numbness and facial swelling in the cheeks approximately 5:30 pm. Dr. assisted, patients pulse was strong with O2 saturation was 99% with pulse 93. She reported, chills, and feeling worse and was administered Benadryl 25mg at 5:30. She reported numbness in her arms. She was removed from her car to lay down with feet elevated. 911 was called for transport due to decreased sensation in her hands and arms and increased heart rate. At this time patients heart rate was up and down, and about 119 An Epi Pen was administered at 5:45. Ambulance arrived at bout 6:00 pm, then transported to Hospital.
quite sick; This case was reported by a consumer and described the occurrence of sickness in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th December 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingrix.  Additional details were reported as follows: On 30th December 2019, the patient received 1st dose of Shingrix and experienced sickness. The patient's pharmacist informed to the patient due to COVID-19 they are not administrating the vaccine now. The patient asked recommendation form GSK, since the patient don't want to miss the prescribed protocol by putting off the 2nd dose of vaccine.
Received ZOSTAVAX inj-Wedn next day, site was swollen, hot and red but small (3 in) by Friday, rash spread/redness spread and lump is palpable (walnut) and is itchy-pt also rec'd flu shot on 11/26/14.
Pain in shoulder and arm and as time passed not being able to lift left arm (starting in the early Fall 2021 and continuing).  Lymphoma (large B Cell) in left shoulder and arm.  4 cycles of chemo, major surgery on left shoulder and arm (reconstruction of shoulder with titanium) and removal of cancer, 21 days of radiation and currently starting physical therapy for range of motion of left shoulder and arm.
2 day expired Pentacel was administered to a patient with No adverse event; Initial information regarding an unsolicited valid non-serious case received on 30-Oct-2020 from a non-healthcare professional (patient's relative) via call center.  This case involves a 7 months old female patient who received Vaccine Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Mrc5)/Hib(Prp/T) Vaccine [Pentacel] and 1 doses of 0.5 ml, 2 day expired Pentacel was administered to a patient (Expired product administered) (batch number: U6218AA UJ016AA and expiration date: 26-Oct-2020) via unknown route in the left thigh for prophylactic vaccination on 29-Oct-2020.  Medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  This was an actual medication error case due to the event expired vaccine used (latency: unknown).  At the time of reporting, no adverse event was reported.  No laboratory data was reported.  Disclaimer: this suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in directive 2001/83/ec and module VI of the good Pharmacovigilance practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
During the post-vaccination observation period, vaccine recipient complained of vertigo and some mid-sternal chest pain. They were seen by EMS and the cardiac monitor showed abnormal rhythm. They were transported to emergency department Medical Center. They reported chest pressure and near syncope. During reexamination, there was no chest pain or palpitations. They were discharged to home. Registered 03/05/2021 11:37 AM, Discharged 03/05/2021 4:38 PM.
Patient presented to PCP on 05/18/2021 office from group home with C/O  cough, runny nose, lethargic, fever, lungs rattling, uncontrollable shaking. Patient had a seizure the night before and had been having weak spells and coughing and fever since that time. Patient admitted to hospital on 05/18/2021 and chest Xray showed pneumonia.  Patient tested for COVID-19 on 05/21/2021 after learning of potential exposure at group home and result was positive.
Cancer - pleural effusion covering right lung, pleural mass and diagnosis of Ewing?s sarcoma after second dose of vaccine
Patient reported muscle pain/soreness on 10/25/17 and still is reporting muscle pain on 10/27/2017.
Information has been received from a healthcare worker referring to a female child of unknown age. On 18-FEB-2015 (reported as "yesterday") the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB, 0.5 ml in her right thigh (lot# and route unspecified). No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Greater than 36 days separation between first and second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Greater than 36 days separation between first and second dose) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K28) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Greater than 36 days separation between first and second dose). On 26-Jan-2021, PRODUCT DOSE OMISSION ISSUE (Greater than 36 days separation between first and second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided. No treatment information was provided. Reportedly, the patient received her first dose on 26-Jan-2021 but due to a number of factors, the patient couldn't follow up on her second vaccine until 07-Jun-2021.
Per mom, pt. required ER visit with temp of 103 degrees the night of immunizations and could not get it down to 100 degrees the following day. In addition pt. developed a cough & diarrhea. Parent instructed to alternate TYLENOL and Ibuprofen for fever and Pedialyte for diarrhea. Prescriptions for these were called to pharmacy. Parents instructed to return to ER over weekend if sx worsen.