chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a medical assistant refers to a female patient of unknown age. The patient's current conditions or medical history were not reported. On an unknown date the patient was vaccinated with a dose of GARDASIL (dose, route, lot and expiration date were not reported). On an unknown date, the medical assistant reported that an unspecified patient's mother reported to her that the daughter of the mother's friend experienced heavy menstrual bleeding after receiving GARDASIL. At the time of the report, outcome for heavy menstrual bleeding was unknown. This is one of two reports from the same source. Additional information is not expected.
Deep vein thrombosis occurring 12 days after 2nd vaccine.  No previous DVT in lifetime.
Information has been received from the patient's husband referring to the 69 year old female patient. The patient's medical history included pacemaker and defibrillator implant insertion (dates were unknown). The patient had no drug reactions/allergies. "2 years ago, on an unspecified date in 2013 the patient was vaccinated with a dose of ZOSTAVAX (lot#, route not reported, 1 single shot). On 17-MAR-2015 the patient developed shingles. The patient had sought medical attention via speaking with physician. TYLENOL and codeine (dosages/frequencies/manufacturers unknown) were given for the event. No lab tests were performed. At time of this report, the patient did not recover from the event. The causality was not reported. Additional information has been requested.
received both doses; second dose less than 2 month apart of the 1 dose; - received both doses; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 36-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number AP545, expiry date 25th January 2023) and (batch number KS4T7, expiry date unknown) for prophylaxis.   On 19th October 2021, the patient received the 1st dose of Shingrix. On 3rd September 2021, the patient received the 1st dose of Shingrix. On an unknown date, the dose was an unknown dose. On 3rd September 2021, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On 19th October 2021, the patient experienced inappropriate age at vaccine administration and drug dose administration interval too short. On an unknown date, the outcome of the inappropriate age at vaccine administration, inappropriate age at vaccine administration and drug dose administration interval too short were unknown.  Additional details were provided as follows: The patient received 1st dose on 3rd September 2021, batch number AP545 expiry date 25th January 2023, batch number KS4T7. The patient received 2nd dose of Shingrix less than 2 month apart of the 1 dose, which led to shortening of vaccination schedule. The patient received 1st and 2nd dose of shingrix at the age of 36 years old, which led to inappropriate age at vaccine administration. The reporter consented to follow up.
I developed severe pain in my left arm at the injection site. I had a frozen shoulder the following day. This lasted for about 3 days and then gradually improved over the next several weeks. I also woke up the night of the vaccination with chills. These were alleviated with sweat pants and a sweat shirt, although it was not cold in the room. I had malaise and fatigue for the following 3 days.
Blotchy red rash. Pain in left arm, and from left elbow to left shoulder and left breast.
Information has been received from a physician and a practice manager via two company representatives referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were unknown. On 21-JUN-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5 ml (lot # L010598, expiration date 06-AUG-2016, route unknown). The total cumulative excursion time was 24 hours with the highest recorded temperature of 47 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Information has been received from a physician concerning a male patient who on approximately 12-JUL-2010 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # unknown). The physician reported that the patient had a "blister herpes type zoster rash". Patient was not hospitalized and was seen in the physician's office on 02-AUG-2010. At the time of the report, the patient had not recovered. Additional information has been requested.
Pain at the injection site/ tenderness at the injection site; Swelling at the injection site; Injection site warmth; Injection site redness; Fevers; Body warmth; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis, MMR (MEASLES/MUMPS/RUBELLA) for prophylaxis and PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE) for prophylaxis.   On 8th September 2020, the patient received the 1st dose of Shingrix, Influenza vaccine Quadrivalent 2020-2021 season, MMR (MEASLES/MUMPS/RUBELLA) and PNEUMONIA VACCINE. On 9th September 2020, 1 days after receiving Shingrix and Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced injection site pain, injection site swelling, injection site warmth, injection site erythema, fever and feeling of warmth. On 15th September 2020, the outcome of the injection site pain and injection site swelling were recovered/resolved. On an unknown date, the outcome of the injection site warmth, injection site erythema, fever and feeling of warmth were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site swelling, injection site warmth, injection site erythema, fever and feeling of warmth to be related to Shingrix and Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were provided as follows: The patient had received Shingrix along with three other vaccines (unknown manufacturers influenza, MMR, and Pneumonia) on 8th September 2020. She received all 4 vaccinations in her left arm on that day.  The patient developed pain and swelling at the injection site, next day after vaccination date which got resolved later. She also developed redness, warmth and tenderness at injection site next day after vaccination date, which had not resolved till the time of reporting. She further developed fevers, "body warmth" that "came and went" that started on next day of vaccination date and continued to be ongoing. The reporter who was related to the patient consented to follow-up and gave consent to follow-up at HCP. The patient would briefly confirm details on the call. It was unknown if the reporter considered the injection site pain, injection site swelling, injection site inflammation, fever and feeling of warmth to be related to MMR and PNEUMONIA VACCINE.
Tinnitus; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Apr2022 at 13:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 60 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LITHIUM; QUETIAPINE; SYNTHROID; LINZESS. Past drug history included: Risperidone, reaction(s): "Allergy". Vaccination history included: shingrx (Dose:2, vaccine_location=Left arm), administration date: 03Mar2022; Bnt162b2 (1st Dose), for Covid-19 Immunization; Bnt162b2 (2nd Dose), for Covid-19 Immunization; Bnt162b2 (3rd Dose), for Covid-19 Immunization. The following information was reported: TINNITUS (disability) with onset 22Apr2022, outcome "not recovered". Therapeutic measures were not taken as a result of tinnitus. Prior to vaccination, the patient was not diagnosed with COVID-19 and Since the vaccination, the patient been was not been tested for COVID-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Dose 1 Pfizer given 2/19/2021 lot # EN6203  Patient had a cardiac arrest at home and died in the emergency room.
After second immunization with Gardasil, patient developed pruritus arms, trunk, legs - at time erythema - unresponsive to OTC creams. Benadryl. Then had third immunization - pruritus even worse. At Student Health given Prednisone - helped on higher dose only. Rash now sand paper appearance arms, legs, trunk - pruritic. PArient found to have scabies by dermatologist. So not a GARDISIL reaction
The primary reporter for this case is the field representative. The representative indicated the doctor stated that patient was administered ZOSTAVAX and the flu vaccine in the same arm on the same day. The representative indicated the doctor stated the patient had a red swelling at the injection site and fever. No further information is available.
hives, tingling in lips, no SOB or nausea, had similar reaction with 1st vaccine , improved significantly after Benadryl but hives persist although itchiness much better
Case number PHEH2013US003756 is an initial spontaneous report received from a pharmacist on 08 Feb 2013. This case refers to a 37-year-old male patient. He was vaccinated with an expired MENVEO (batch number: M10053, expiration date: 31 Jan 2013) intramuscularly on 05 Feb 2013. No adverse event was reported following vaccination.
Heart  Palpatations started first lasted about 15 minutes, then sore throat, congestion, body aches and severe fatigue, injection site pain and chills.
Patient is a 56-year-old female who is self-referred for evaluation of right arm following hepatitis A vaccination injection. Patient states she had hepatitis A vaccination injection and proximal right upper extremity on 10/8/18. Patient states 2-3 weeks following injection, 2 knots appeared on her right upper extremity. States that these knots increased in size, became red and eventually busted. States that the area is drained puslike fluid. States that the 2 areas on her proximal right upper extremity were very tender, but have since improved. Rates pain currently as 3/10. States that the areas last drained about 1 month ago. Denies fever, chills, sweats. Denies ever having a reaction like this before. States that she has had a cough since she had the injection. Follow-up as needed.
10JUN97 pt came into office w/clinical case of varicella about 30 papule vesicular lesions;
Red, swollen area with hard knot to both legs at injection site.  Patient's parent called and reported reaction 24 hours after vaccine was administered.
8:00 pm I'm starting to feel chills 9:00 pm pain in the bones 10:00 pm fever 102.4 11:00 to 12:00 pm swelling of the face (eyes, nose, mouth)
Breakthrough case admission after 4 vaccines MOderna 2/2/21 lot# 013M20A;  Moderna 3/2/21 lot# 010A21A;  Moderna 11/12/21 lot# 034F21A;  Moderna 7/25/22 lot# FJ2602
35M notes since receiving his flu shot on Friday, his entire left arm, from the clavicle to hand hurts, ranging from 1/10 to a shooting 8/10, with a tingling sensation to his fingers. Constant px, regardless of whether he's moving it or not. He's attempted relief c tiger balm, salonpas, ibuprofen 200mg, massage, ice, heat, with no effect. Suspects it is progressively getting worse. Pt notes that relief is found when engaging arm, such as carrying groceries. Denies any cold or flu-like symptoms.  Upon visual exam, vaccine site is unremarkable. Full PROM, AROM. STR +4, Speeds and Yergason test reduce px.  Prescribed Gabapentin, 300 MG, CAPSULE, ORAL TAKE ONE TABLET BY MOUTH THREE TIMES A DAY AS NEEDED FOR PAIN OR NUMBNESS #30 RF0, f/u c provider in 1wk.
Patient has had hiccups since receiving the vaccine (6 days). They have not responded to treatments given to him by him MD including multiple medications
Widespread redness on upper right arm beginning the day after receiving vaccinations (December 31, 2022); pain in upper right arm that continues to the present. Patient received prescriptions for Bactrim DS, famotidine, and prednisone, plus instructions to take diphenhydramine, on January 4, 2023 from a local emergency center.
This spontaneous report as received from a pharmacist refers to a 44 years old female patient. The patient was allergic to penicillin. The patients medical history included rheumatoid arthritis. On 22-JAN-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot number H019997 and expiry date was February 2014. Dose was not reported) subcutaneously. Concomitant medications included CHANTIX, BACTRIM, promethazine, omeprazole, acetaminophen, PERCOCET, methadone hydrochloride, tizanidine hydrochloride, gabapentin, sumatriptan, lisinopril, clonazepam and levothyroxine sodium. On 23-JAN-2013, the injection site of the patient who received ZOSTAVAX was swollen, red, hot to touch and it felt like there was a knot there. The patient sought medical attention (details unspecified) and was treated with ice. The events were not recovered. Additional information has been requested.
Reactivation of genital herpes; also occurred 2 days following 2nd dose of Pfizer-BioNTech Covid vaccine
Rt arm became stiff and painful within 4 hours of shot. Was unable to sleep through the night due to the pain. In morning, during my shower I became light headed and nauseous and past out for unspecified amt. of time. Red rash developed on stomach. Took 2 Benadryl at 6:30. Called health serviced around 8 who advised me to go to the ER to be checked out.
itching on lower arms with red bumps was reported as worsened; tired; a little sore throat on right side; achy; sick a couple of days before; little red bumps starting to travel up her arms; after developed itching on both lower arms/itching on both lower arms started out on the elbow down towards the hand on both arms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 59 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Aug2021 (Lot number: FA7485) at the age of 59 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "MS", start date: 2003 (ongoing), notes: Additional Information for Other Conditions: diagnosed in 2003. There were no concomitant medications. Vaccination history included: Bnt162b2 (First dose, Lot number: FA6780), for Covid-19 immunization. The following information was reported: RASH MACULAR (non-serious) with onset Aug2021, outcome "not recovered", described as "little red bumps starting to travel up her arms"; PRURITUS (non-serious) with onset Aug2021, outcome "not recovered", described as "after developed itching on both lower arms/itching on both lower arms started out on the elbow down towards the hand on both arms"; CONDITION AGGRAVATED (non-serious), outcome "not recovered", described as "itching on lower arms with red bumps was reported as worsened"; FATIGUE (non-serious), outcome "unknown", described as "tired"; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "a little sore throat on right side"; ILLNESS (non-serious) with onset Sep2021, outcome "unknown", described as "sick a couple of days before"; PAIN (non-serious), outcome "unknown", described as "achy".  Additional information: Patient stated she wanted to call, she got the Pfizer Covid vaccine on 21Aug2021 and after the second one, about a week after, she has developed itching on just her lower arm, both of them, has somewhat little red bumps and was hoping it would all disappear but appears to be traveling up the arm, was sick a couple of days before, states she was achy, tired, had a little sore throat on right side, stated there were no fever and no breathing issues. Exact dates unknown.  No follow-up attempts are possible. No further information is expected.
Pt got RSV from a different facility in the right arm. Pt also got Tdap and PPSV23 at the same with clinic. Pt states Tdap or PPSV23 was done in the right arm. We are not sure which is correct because of the documentation shows she got Tdap and PPSV in the left arm. Pt has swelling and redness in right arm. Pt came in 10/27/2023 at 1230 to talk about her reaction to the vaccines. Pt was seen by Dr. in clinic.
very sore arm, could not lift it, fatigue hit almost 24 hours exactly after injection, rash the following day over chest and neck
15:30 complete, injection site warmth. VS: T97.5, HR 108, 95% SpO2, BP 162/72. Patient monitored for 10 more minutes, doctor notified. Patient cleared. Second set of vitals obtain: HR 113, BP 139.67, 100% SpO2.
Patient received Tdap IM R arm on 4-8-09. Right arm red and swollen; warm to touch. Good ROM. Pt. state she took pain medication for discomfort. Encouraged to have doctor check. States she will have a doctor check her arm. Measured LPN not to touch measured area 3 x 4 1/2.
Syncope immediately after injection. Head hit on wall on exam room. Patient began with seizure activity lasting less then one minute. EMS called. Oxygen and pulse oximetry monitoring in place. Taken by ambulance to ED once stable.
Patient described feeling itchiness on forearm and back. Noted with small rash on forearm. Patient denied any other symptoms.  Benedryl 12.5mg X 2  tablets  given by mouth at 1:33pm. At 2:00pm symptoms resolved and patient was discharged.
Fever; Fatigue; Chills; Body aches; This is a spontaneous report from a contactable consumer (patient). A 48-year-old non pregnant female patient received bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE Solution for injection Lot number was not reported) via an unspecified route of administration in arm left on 24Feb2021 14:15 as dose 1, single (age at vaccination: 48 years) for COVID-19 immunisation. Medical history included Known allergies: Sulfa from an unknown date and unknown if ongoing, COVID-19 from an unknown date and unknown if ongoing If covid prior vaccination: Yes. Concomitant medications included paracetamol (TYLENOL), multi vitamin taken for an unspecified indication, start and stop date were not reported. No other vaccine in four weeks. COVID prior vaccination and did not tested COVID post vaccination. On an unspecified date 2021, the patient experienced fever, fatigue, chills, body aches after both vaccines. No treatment was received. The clinical outcome of the events on an unspecified date 2021 was resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
A couple of hours later I had arm pain, fatigue, body aches & headaches. The symptoms lasted about a week.
This spontaneous report as received from a pharmacist refers to a 50 year old female patient with hypothyroidism and no drug reactions or allergies. On 08-JUN-2013 the patient was vaccinated with ZOSTAVAX (lot # J000443, expiration date 11-APR-2013) 0.65 ml, subcutaneous in the left arm for prevention of shingles. Concomitant therapies included SYNTHROID. Approximately in June 2013 the patient developed a lump under her skin (described as a "round ball"), redness and warmth on her left arm at the injection site after receiving ZOSTAVAX. Patient sought medical attention by coming back to pharmacy, treatment was not given and laboratory tests were not performed. Additional information has been requested.
5 days after the vaccine, my right ear became itchy and red, then became swollen, Next day left ear became itchier than the right ear and swelled more.  Took Xyzal in day and Benadryl at night.  It has continued on , on the 9th day, my head became itchy.  On the morning of the 10th day, my face looks red and rashy with my right eye swollen
Covid-19; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (Covid-19) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Covid-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 21-May-2022 to 26-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Covid-19) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  Relapse of Covid infection symptoms were include sore throat, headache, cough and nasal congestion  No treatment medication were provided.  Device date was reported as 31-May-2022  Company comment: This spontaneous case concerns a 70-year-old female patient with no reported medical history who experienced the unexpected non serious AESI of COVID 19 which occurred unknown days after the administration of third dose of mRNA-1273 vaccine in COVID 19 vaccination series. Patient received NIRMATRELVIR, RITONAVIR (Paxlovid) as treatment for COVID 19 from 21-May to 26-May. Symptoms relapsed 4 days after completion of treatment with Paxlovid and included sore throat, headache, cough and nasal congestion. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 70-year-old female patient with no reported medical history who experienced the unexpected non serious AESI of COVID 19 which occurred unknown days after the administration of third dose of mRNA-1273 vaccine in COVID 19 vaccination series. Patient received NIRMATRELVIR, RITONAVIR (Paxlovid) as treatment for COVID 19 from 21-May to 26-May. Symptoms relapsed 4 days after completion of treatment with Paxlovid and included sore throat, headache, cough and nasal congestion. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Lip swelling approximately 5 hours after vaccine, rash starting 3 weeks after vaccine on palms of hands and soles of feet.
After a few days  the non diabetic neuropathy in my feet was much much worse and even started in my lower calves.  I also have noticed  occasional ringing in my ears. ,The neuropathy has continued to be much much worse!  Not improving.  This is a serious issue for people like me who are trying desperately to get relief from neuropathy and there was no warning this could be aggravated or maybe even worsened permanently by this vaccine.
pt recvd vax 11AUG92 4PM & exp hives over upper thighs, arms, face-hives over body @ 930 when seen by MD;