chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received my flu shot on Tuesday 10/5 at the POD.  Received my 3rd Covid booster on 10/8 @11:30.  Typical arm pain at injection site (received both vaccines in the right arm).  Headache on Saturday and Sunday. Sunday morning woke up (actually so painful it woke me up) with underarm pain and a lot of swelling.  Swelling can fit into the palm of my hand (baseball sized).  Very sore today (under arm) when moving my arm.  I know that it can swell but didn?t have this before and never had Lymph swelling under my arm from a vaccine.  Headache now gone. No fever or anything.  I am sure this will go away with time.  Just wasn?t sure if I needed to report it or not.  Haven?t had it before.
Feels awful and brain not working; Feels awful and brain not working; COVID vaccine/gotten sick; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-ABBVIE-4229502.  A 73-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; upadacitinib (RINVOQ), (Batch/Lot number: unknown) oral. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MENTAL IMPAIRMENT (medically significant), FEELING ABNORMAL (non-serious), outcome "unknown" and all described as "Feels awful and brain not working"; ILLNESS (non-serious), outcome "unknown", described as "COVID vaccine/gotten sick".  The reporter's assessment of the causal relationship of "feels awful and brain not working" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The reporter considered "covid vaccine/gotten sick" related to BNT162b2.  Clinical course: The reporter's causality for the event(s) of Covid vaccine/gotten sick, Feels awful and brain not working with Upadacitinib was Reasonable Possibility. The reporter's causality for the event(s) of Covid vaccine/gotten sick with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Reasonable Possibility .   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
experienced nerve pain near the wrist 10 mins after the vaccination, and also experinced chills, fever, and arm soreness from the next day of vaccination
Slightly swollen, extreme pain, unable to lift arm and unable to pick anything up. Left arm.
fever of 104 6 days p/vax; rash devel on torso 4 days later; pt was seen in ofc 1 day p/rash onset & rash was almost imperceptible; pt was active & did not appear ill; PMD feels this is secondary to MMR vax
Hives on chest developed 6 hrs after vaccine. Injection site red, swollen, size of silver dollar. Patient treated w/ antihistamines.
Information has been received from a health professional concerning a 9 year old white male with no pre existing allergies, birth defects or medical conditions who on 09/16/1997 was vaccinated with  a dose of varicella virus vaccine live. On 08/18/2004 developed chickenpox. Subsequently the pt recovered from the chickenpox. Additional infomation has been requested.
After the shot my arm was very sore and then later that evening became more sensitive. When I woke up the next day left arm was swollen upon about 1/3 larger than normal it was like a huge lump soar and swollen it seemed to swell larger and was very hard as the day went on. It remained like that for about 1 1/2 weeks then slowly went down. The arm is still slightly different to the other.
Information has been received from a physician concerning a 5 year old patient who on 4/18/2001 was vaccinated with a dose of varicella virus vaccine live. Concomitant vaccine administered together with varicella virus vaccine live included a dose of measles virus vaccine live  (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). It was reported that the patient was seen on 4/28/2005 with breakthrough varicella with several lesions on the left arm and leg, and no fever. Subsequently, the patient recovered. Follow up information from a physician indicated that the patient experienced chickenpox, described as mild with only 10 to 15 skin lesion. Additional information is not expected.
Starting around 1:00 am (almost exactly 12 hours following vaccination), patient experienced chills (alternating hot/cold sensations, sometimes hot/cold at the same time in different body parts), violent shaking/shivering, fever ranging from 99.9 to 102 degrees F (even after taking 400-600 mg of ibuprofen every 6 hours), body aches / pains in virtually all bones and muscles, and some organs (painful ear drums, eyelids, swallowing room temperature liquid felt painful in esophagus but no throat soreness); moving muscles to change position felt like bones would break and/or muscles / ligaments would tear; unable to find a singular comfortable position; unable to sleep; heart racing while in resting / reclined position - watch showed 15+ minutes of "fat burning" heart rate and "5 floors climbed", despite lying reclined and trying to sleep for more than 8 hours (having not walked more than about 1000 steps in the day to use the bathroom and drink fluids).  The following day, fever broke, but patient woke sweating with a temperature of 96.6 degrees F (lower than the patient's average temp in the 97s-98.6 range). Body aches were mild to moderate, but mild nausea and diarrhea were experienced for all waking hours, and appetite was less than normal. Exhaustion still experienced in the third day (today 4/24), and body aches mild. No known fever at this time.
Patient felt nauseous and dizzy after the vaccine. Call 911. They checked patient's vitals and patient  was doing better and was sent home. No other adverse effects reported.
After the second dose, within an hour and a half, severe muscle cramps, nausea, headache, nightmares, insomnia, lack of anti anxiety meds working, no appetite, feverish, restless, chills, legs would not stay still out of pain. Took pain reliever, but not as effective as usual. This is referring to 04/24/21 vaccine. 04/1/21 vaccine had very short term mild flu symptoms that went away.
Out of work (major/ terrilbe reactions); Felt like the flu (major/ terrible reactions); This case was reported by a consumer via interactive digital media and described the occurrence of inability to work in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced inability to work and influenza-like symptoms. On an unknown date, the outcome of the inability to work and influenza-like symptoms were unknown.   It was unknown if the reporter considered the inability to work and influenza-like symptoms to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 30-SEP-2022 Reporter's Comments: This case was reported by a patient via interactive digital media. The patient had major reaction to vaccine. The patient was out of work and felt like the flu with terrible reaction. The patient was scared of 2nd shot. Follow-up would not possible as no contact details were available.
Information has been received from a registered nurse concerning a patient who was  vaccinated with a dose of varicella virus vaccine live (Oka/Merck). In December 2007 the patient's mother reported the patient developed a rash which she thought looked like chickenpox. The nurse indicated the patient would be seen in the office later on this afternoon. At the time of reporting that patient's status was unknown. The nurse reported they were having a lot of cases of chickenpox in their office, sometimes 1-2 cases a week. Most of the cases were following varicella virus vaccine live (Oka/Merck). She further explained that they have been reporting the cases via the rep and also to the state. This is one of several reports received from the same source. Additional information has been requested.
FEVER; SHAKES; CHILLS; This spontaneous report received from a patient concerned a female of unspecified age. 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: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced fever, shakes, and chills. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 101 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, shakes and chills was not reported. This report was non-serious.
Pt called the pharmacy the next afternoon reporting chills, facial flushing, upset stomach, and diarrhea. The injection site was also inflamed and warm to the touch. She reported that these symptoms started the day after her vaccination. The pharmacist followed up with the patient the next morning (2 days after vaccination) and pt reported that some symptoms had resolved, but she was still experiencing stomach upset and diarrhea. Pt reported receiving flu shots in the past and never having any issues or adverse effects.
Pt rec'd 12 mo imm at ear (OM) RE-check appt 1/21/14. Fever began that PM (101 - 103 degrees). No site reactions noted. To tx fever with APAP/ibuprofen prn; Increase fluids and call office if no improved in 1 -2 days.
panicking; can receive his shot when and if he gets out of the hospital on time; This is a spontaneous report from a contactable consumer (patient's wife) via Medical Information Team. A 63-years-old male patient received first dose of bnt162b2(Pfizer COVID-19 Vaccine, formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Reporter inquired about her husband who is currently in the hospital. He has his second shot of the Pfizer BioNTech COVID19 vaccine scheduled on Saturday. She is wondering if he can receive his shot when and if he gets out of the hospital on time. If he does not get out on time, what should he do. It was reported that he is panicking because the appointment is coming up. She says the hospitalization is not caused by the vaccine since he "gets like this when the weather changes" also states that she will ask his providing doctor the same question. Response was reporter referred back to HCP since she is asking for medical advice: Because your doctor/healthcare provider is most familiar with your medical condition, clinical history, how your treatment has been conducted and any relevant information to your specific case, your doctor/healthcare provider is in the best position to advise you about the appropriate action to take. Therapeutic measures included Zpack. Outcome of the event was Unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient had Rash appear all over body. Patient was treated with Benadryl and anti-itch cream and symptoms resolved over the next few days
This spontaneous report as received from a registered pharmacist via company representative refers to a 29 years old female patient. Current conditions included Crohn's disease and bronchospasms. On an unspecified date, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date and dose were unspecified) subcutaneously. Other suspect therapies included PNEUMOVAX 23 (lot number, expiry date, route and dose were unspecified0. Concomitant medications included: INTRACORT. On an unknown date, the patient did not eat for several days while on ZOSTAVAX and experienced shingles. It was unspecified if the patient sought medical attention. Treatment information was unspecified. It was unspecified if lab studies were performed. The outcome of all the reported events was unknown. Additional information has been requested.
Sore and swollen arm. Sudden, generalized weakness. Fever. Next period much heavier than normal. Heavier, but shorter.
Fever, chills, muscle ache, head ache, nausea. Took 1 gram of tylenol every 8 hours. Symptoms lasted about 20 hours
hair loss and hair thinning shortly after receiving the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 82 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 2021 (Batch/Lot number: unknown) at the age of 82 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Route, Anatomical Location: right upper arm , Caller state she had them both in the beginning of last year, 2021.), administration date: 2021, for Covid-19 Immunization. The following information was reported: ALOPECIA (non-serious), outcome "not recovered", described as "hair loss and hair thinning shortly after receiving the vaccine". Therapeutic measures were not taken as a result of alopecia.  Additional Information: Patient doctor and her dermatologist have already told her this might be related to the Pfizer-BioNTech COVID-19.All started not long after her second shot. Event had gotten definitely worse. AE(s) did not required a visit to emergency room, physician office,it had been a gradual thing that was getting more and more apparent. Patient had no prior vaccination within 4 weeks and had no AE following prior vaccinations. Patient had no family history relevant to AE.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200056623 same reporter/drug/event, different patient
high pitched crying began shortly p/immun; partial sz L&R; eyes rolling to back adm 16JAN93;
This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 63-year-old female patient who received SHINGRIX (batch number 32ZG4, expiry date 9th July 2021) for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced pain in arm, swelling, influenza-like symptoms and fatigue. On an unknown date, the outcome of the pain in arm, swelling, influenza-like symptoms and fatigue were unknown. It was unknown if the reporter considered the pain in arm, swelling, influenza-like symptoms and fatigue to be related to SHINGRIX. Additional details were provided as follows: The patient experienced severe arm pain, swelling, flu-like symptoms and fatigue within 24 hours of vaccination. The reporter had consented to follow up.
DX WITH COVID ON 10/26/2020; FULLY VACCINATED, LAST VACCINE RECIEVED ON 02/01/2021; PATIENT EXPIRED ON 03/15/2021; COVID 19 INDICATED ON DEATH CERTIFICATE.
Itchy no pain. Rash that turned into  blisters on the opposite side of the shot. She went to the Doctor and was treated with Zovirax and Acyclon tablets. Patient reported that after few days the blisters and rash went away and she is feeling well.
lesion or cyst that is on the side of her right arm; it hurts to lift her arm at the injection site; right arm hurts and it hurts to lift her arm at the injection site; effecting her exercise; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose 2, single (Batch/Lot number: unknown) at the age of 43 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Anatomical location: in her right arm), when the patient was 43 years old, for covid-19 immunization; Hepatitis b (she had a Hepatitis B vaccine in her left arm), for Immunization. The following information was reported: LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 2021, outcome "not recovered", described as "effecting her exercise"; VACCINATION SITE JOINT MOVEMENT IMPAIRMENT (non-serious) with onset 2021, outcome "not recovered", described as "it hurts to lift her arm at the injection site"; VACCINATION SITE CYST (medically significant) with onset 2021, outcome "not recovered", described as "lesion or cyst that is on the side of her right arm"; VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "not recovered", described as "right arm hurts and it hurts to lift her arm at the injection site". The events "lesion or cyst that is on the side of her right arm", "it hurts to lift her arm at the injection site", "right arm hurts and it hurts to lift her arm at the injection site" and "effecting her exercise" required physician office visit. Therapeutic measures were taken as a result of vaccination site cyst.  Clinical course: Vaccination facility type was hospital and not facility type. Vaccine Second Dose was taken in the morning. Caller reported that she received both Pfizer Covid 19 vaccines purposely administered in the same arm, her right arm. Caller stated that she had a Hepatitis B vaccine in her left arm. Caller states that she was going to have to go to a Cosmetic Surgeon to remove a lesion or cyst that was on the side of her right arm from the Covid Vaccine. Caller stated that her right arm hurt and it hurts to lift her arm at the injection site. Reported that she was having issues with her right  arm and she could feel it, it was a pretty good size. She had to get an ultrasound done to see if it was connected to her muscle and tissue and then went to the Cosmetic Surgeon. It was also effecting her exercise. The lesion/cyst and arm hurting started shortly after her second vaccination, which was either in Nov2021 or Dec2021.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
swollen lymph nodes/ almost all lymph nodes were swollen for the first few days, then only my neck and left underarm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02May2021 as dose 2, single (Lot number: EW0170) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies Shellfish" (unspecified if ongoing); "Heart palpitations" (unspecified if ongoing); "Heart palpitations (SVT)" (unspecified if ongoing). Concomitant medication(s) included: PROPRANOLOL; NAPROXEN; AMBEREN; BIOTIN. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot number: EW0150, Anatomical location: Left arm, Time of administration: 13.15), administration date: 10Apr2021, when the patient was 52-year-old, for COVID-19 immunization, reaction(s): "For the first 2 shots the swollen lymph nodes", "some joint pain", "the morning after: some joint pain, severe pain in spine", "about 24 hours after shot: swollen hands and feet", "About 48 hours after shot: sore, swollen lymph nodes". The following information was reported: LYMPHADENOPATHY (non-serious), outcome "recovered", described as "swollen lymph nodes/ almost all lymph nodes were swollen for the first few days, then only my neck and left underarm".  Additional information: The patient did not receive other vaccine in four weeks. The patient did not have Covid prior to vaccination. For the first 2 shots, the swollen lymph nodes lasted 3 weeks but almost all lymph nodes were swollen for the first few days, then only neck and left underarm. The patient was not tested positive for Covid post vaccination.
Seizures ×3+, admission to hospital, fever, anorexia, irritability.
During week between vaccination and symptom onset, right arm had "knot" about the size of ping pong ball that would fluctuate between being slightly red/pink and itchy/not as itchy and didn't seem to change in size.  On Friday 10/22 I started to get what seemed like a tension headache early in the afternoon.  I took ibuprofen and finished my work day.  When I got home from work I didn't feel well but couldn't pinpoint why.  Wasn't able to finish dinner due to low appetite.  I took temperature  (forehead thermometer) and it was OK at that time.  I took some Tylenol and went to bed early.  I woke up in the middle of the night with severe chills/rigors.  Took temperature (under tongue) and it was 102.  Took home COVID antigen test - it was negative.  Was achy/shivering.  Took ibuprofen which seemed to help symptoms.  Next day, noticed the "knot" in my right arm had become smaller but that I had a large area that was red and warm instead around the area of the vaccine.  This area was warmer than the rest of my arm/body.  Also had 2 hive-looking dots on same arm/forearm and another small area of redness on forearm.  Still had pain in occipital area.  Had persistent chills & fever of 100-101 that would reappear whenever ibuprofen wore off (about every 4-6 hours).  Had lack of appetite (no N/V) on Saturday 10/23.  On Sunday 10/24, fever max was 100.4 and ibuprofen kept it lower for longer (~8-10 hours).  Arm redness was lighter this day and not as warm.  Residual "knot" had dissipated but there was still one area that was slightly harder.   Occipital tenderness resolved Sunday evening.   By Sunday evening I had no fever, no occipital tenderness, and no aches.  10/25 & 10/26 the occipital tenderness has fluctuated and I have some fatigue but otherwise feel OK.  Arm is still slightly pink in the area that was red - there is no longer any hard areas.
Received shot on 9/16/09. Very dizzy by 9/18/09. Seen and treated in the ER.
Diagnosed with palsy of the sixth nerve of the right eye; Double vision in right eye; This case was reported by a nurse via call center representative and described the occurrence of vith nerve palsy in a 90-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th September 2019, the patient received the 1st dose of Shingrix (intramuscular). On 8th November 2019, 57 days after receiving Shingrix, the patient experienced vith nerve palsy (serious criteria GSK medically significant) and double vision. On an unknown date, the outcome of the vith nerve palsy and double vision were unknown.   It was unknown if the reporter considered the vith nerve palsy and double vision to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in left deltoid. The patient was a retired who develop double vision in her right eye. On 8th November 2019, she was seen by an ophthalmologist who diagnosed her with palsy of the sixth nerve of the right eye. Additional information was not provided. The reporter did not consent to follow up.
Patient presented to pharmacy with a red rash at site of injection. She stated it hurt and itched.