chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from medical records concerning a 9 week old male pt, whose mother was vaccinated with VARIVAX during pregnancy (WAES0405USA00271). He was born at 39 weeks, a normal live male infant weighing 280 grams, had no congenital anomalies, no feature of congenital varicella zoster syndrome and no other complications. It was noted that he was vaccinated with a first dose of RECOMBIVAX HB (manf unk), on an unspecified date in July 2004. During an office visit at seven days old the infants umbilical stump was present and the circumcised area was healing nicely. On 23Sep04 the pt presented for a 2 month old well child check and two month injections. He showed good development. On examination he had several white bumps on his face and an erythematous macular rash that diffusely spread over his body. The pt was assessed to have cutis marmorata and milia on his face. The plan was to reassure and have him return to the clinic in two months for a well child check. The following 2 month vaccinations were administered a first dose of hep B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (Lot 647595/0027P) in the right leg, first dose of Infanrix (lot 632A2) in the left leg, first dose of Ipol (lot X0771) in the left leg and a first dose of Prevnar (lot 495222) in the right leg. The medical records report that the pt also received the following other vaccinations: 18Nov04 a second dose of COMVAX (lot 647905/0240P) administered IM in the left leg, a second dose of Infanrix (lot 634A2) administered IM in the left leg, second dose of Ipol (lot X0771) administered SC in the left arm, and a second dose of Prevnar (lotA67185) administered in the left thigh on 13Oct05 a third dose of COMVAX (lot 0160R) administered IM in the right leg, poliovirus vaccine inactivated (unspecified) (lotY0298) SC in the left leg and Infanrix (lot AC14AA) IM in the left leg. Information received on 26Oct05 contained the following adverse experiences: feverish on and off for one week (22Jun05); constipation (29Jun05); viral upper respiratory infection (19Jul05); pulling his ears (19Jul05; not eating good (19Jul05); cranky (19Jul05); mild viral upper respiratory infection (13Oct05). Additional information is expected.
Pt recvd 1st dose of Hep B vax (Recomb) on 6MAY91 & exp nausea, weakness, fatigue, fever, anorexia, abd cramps, SOb, & scleral jaundice; pt later recovered;
Headache Chills Fatigue Muscle aches Arm pain  All beginning 24hr after receiving dose throughout the day
Initial and follow up information has been received from a licensed practical nurse via a company representative, concerning a 12 year old white female student, who on 06 Nov 2006 was vaccinated in the right deltoid with 0.5 ml of the first dose of Gardasil. There was no concomitant medication. There was no illness at the time of vaccination. The patient passed out in the physician's waiting room after receiving the vaccination. The patient stated she did not eat breakfast. Upon awakening, the patient was given crackers and soda, and stated she felt better. On 05 Feb 2007, three months after the first dose, the patient was vaccinated in the left deltoid with the second dose of Gardasil. After the second vaccination, the mother called and reported her daughter had passed out at home and hit her head. The patient did not receive medical attention, but her physician was informed. The patient recovered the same day, 05 Feb 2007. Additional information is not expected.
Received influenza injection at school clinic.  School nurse reported softball sized swelling at injection site. Child was given 25mg Benadryl and ice pack.  Mother was called.  Child remained at school.
Itching, escalated to pain and heat, redness, hardness and blisters at and around injection site.
Vaccine administered on 8/19/13. Patient returned on 8/21 with a swollen arm that was red and hot to the touch. Patient is allergic to Diphenhydramine so advised to go to ER.
Injection arm swelled up around 7th/8th day and lasted for an additional week.  Swollen arm, itchy redness and it kept  traveling down my arm.  Went to  my primary doctor around 3/4 day and he prescribed Keflex which I took for 7 days.  Petrified to get my second dose on 3/13/21 (tomorrow).
Information has been received from a mother concerning her 16-month-old daughter who was vaccinated with the first dose of varicella virus vaccine live (Oka/Merck). The patient's mother reported that her daughter developed a rash and was subsequently diagnosed with shingles. Unspecified medical attention was sought. At the time of this report, the outcome was unknown. No further information is available.
COVID-19 booster shot taken on Thursday Dec. 9 at 9:15 am. Around 4:30 pm that day, a fever started along with general achiness. Later that evening, early next morning and throughout the day Friday, her fever got higher 101.9 (peak) and muscle/bone achiness got worse. Very difficult sleeping that Thursday and Friday night. Friday afternoon, the fever began to come down but still elevated. Muscle/bone achiness continued. Saturday morning fever seems to have subsided (temperature between 98.6 and 98.9) but muscle and bone aches/pain continue.
Received injection at 0700. Headache began at 1200, severe by 3 pm. Chills started at 3 pm, by 9 pm were rigors. Also experienced presyncope and severe generalized joint and muscle pain. No treatment sought. On following day all symptoms resolved.
Pt noticed swelling, pain, redness right upper arm on 10/14/06. Symptoms have continued since 10/14/2006. Aleve 2 tablets taken every 6 hours without relief. Right upper arm hot to touch, red. Temperature 99.9 orally.
Information has been received from a consumer concerning "at least 30 children" with no pertinent medical history who were vaccinated with MMR II (lot# unknown). There was no concomitant medication. The consumer reported that she knew "at least 30 children" who had been diagnosed with autism after the children had received the MMR II injection (dose unspecified and route unspecified). No specific details regarding each child was provided. It was unknown if the patients sought any medical attention. Upon internal review, autism was considered as an Other Important Medical event. Additional information is not expected.
Information has been received from a 64-year-old female with asthma and no drug allergies who on 07-OCT-2005 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine.  There was no illness at the time of vaccination.  Concomitant therapy included fluticasone propionate (FLOVENT), ALBUTEROL, montelukast Na, and thyroid.  On 07-OCT-2005, after vaccination, the patient's right arm swelled up to three times the normal size at the injection site area.  The patient also developed pain and redness in the right arm.  Medical attention was not sought and the patient took acetaminophen (TYLENOL) to relieve the pain.  No laboratory/diagnostic tests were performed.  On 10-OCT-2005, the patient's events resolved.  Additional information is not expected.
This case was reported by a consumer via call center representative and described the occurrence of brain neoplasm in a 68-year-old female patient who received SHINGRIX for prophylaxis. On 13th May 2018, the patient received the 1st dose of SHINGRIX. On 26th June 2018, 44 days after receiving SHINGRIX, the patient experienced brain neoplasm (serious criteria GSK medically significant). On an unknown date, the patient experienced influenza-like symptoms, nausea and injection site pain. The patient was treated with non-drug therapy (Radiation) and chemotherapy, nos (Chemotherapy). On an unknown date, the outcome of the brain neoplasm was unknown and the outcome of the influenza-like symptoms, nausea and injection site pain were recovered/resolved. It was unknown if the reporter considered the brain neoplasm, influenza-like symptoms, nausea and injection site pain to be related to SHINGRIX. Additional information received as follows: The case was reported by the patient's husband. The patient was diagnosed with a brain tumor. As treatment, the patient had a resection of the brain tumor. The patient had flu-like symptoms, nausea and some pain at the injection site. The symptoms were lasted about 3 days. The reporter stated he did not believe the tumor was related to SHINGRIX. As per initial report the patient received the vaccine on 12th may 2018 however during follow up the vaccination date was reported as 13th May 2018.
Patient got a minor reaction (did not specify); Injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Patient got a minor reaction (did not specify)) and VACCINATION SITE PAIN (Injection site pain) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Patient got a minor reaction (did not specify)) and VACCINATION SITE PAIN (Injection site pain). At the time of the report, IMMUNISATION REACTION (Patient got a minor reaction (did not specify)) and VACCINATION SITE PAIN (Injection site pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. The DOB of the patient was reported as 1970 (partial date) No treatment medications were reported.
Lip swelling, eyelid swelling, are itching.  Benadryl oral given.  Sent to ER.  2nd day follow-up, no further intervention was given in ER other than benadryl.  At home and feeling "99%" better.
In July 2021 he had one dose of Pfizer vaccine and within 15 minutes he felt 'impending doom', and then heart racing, got tunnel vision, chest pressure, throat constriction and 'felt like he was going to die' and vitals checked by nurse and discharged once he reported to nurse that he felt better a half hour later even though he didn't feel back to baseline.  He was fatigued.  He went home and the second day felt continued fatigue, heart palpitations and SOB, and nausea, chills, fever. The third day, 7/8/21 he started noticing widely fluctuating HR 52 at baseline rose to HR 110 and felt SOB , chest tight and throat tightness and went to ER who did a workup that was inconclusive.  He has had intermittent palpitations since and during workout he is getting SOB that is unusual.  This is a previously active and athletic individual.  Since the vaccine, he has a knot in his throat and feels reflux more (reflux exacerbated from his baseline but stable on Omeprazole now), feels palpitations and tachypnea, SOB with exertion such as weights, and progressively worsening SOB with even moderate intensity walking and with prolonged mask wearing.  This SOB with mask had not occurred pre-vaccine.   Pt has not gone back to the gym since workup including seeing a cardiologist and pulmonologist.   He had a second ER visit on 8/5/21 for this.   Cardiologist ordered Echo and EST and results normal, despite SOB. Holter monitor done but inconclusive with one episode of HR 120. Pt has had an episode of elevated HR 120 with some irregularity on it , and cardiologist ordered CT and MRI and if negative, will have another round of strength training while Holter.  Pt reports strength training at gym resulted in HR fluctuating from 100 down to 42 suddenly on fit bit and he was scared and stopped.  Pulmonologist is ordering PFT and apnea test next.  I performed a spirometry with FEV1 of 72% which is abnormal.  As an allergist, I ordered skin testing to Peg 3350 containing medications today and it was positive.   Peg 3350 is in Miralax and DepoMedrol and is also in the MRNA COVID vaccines by Pfizer.    In summary, Patient is likely one of the rare true IgE mediated PEG - allergic patients who had anaphylaxis to his Pfizer vaccine #1.   What is unusual is his chronic and debilitating respiratory and cardiac abnormalities that continued after his anaphylactic episode.
Information has been received from a registered nurse concerning a patient who between 10/22/2004 and 10/25/2004 was vaccinated with pneumococcal 23v polysaccharide vaccine (lot 647655/0869N).  Subsequently, the patient had a reaction from shoulder to elbow.  The patient was treated with diphenhydramine hcl (Benadryl) and cool compresses as needed.  The patient recovered.
Red rash 24 hours after immunization. Swelling upper left arm after immunization.
The event as stated by the patient's mother:  Got two vaccines during her recent visit - DTaP and Hep B. She is having a reaction in one of her arms (right arm) where she received the vaccine. Her arm is red, hot, and swollen, and has almost a rash-like look. This same thing happened with her last flu shot (December 2019) as well. It looks like she has developed a sensitivity to an ingredient in some vaccines. Her other arm is fine, so it doesn't appear to be all vaccines that produces this reaction.
Her doctor told her it was a rheumatoid arthritis flare up; This is a spontaneous report from a contactable nurse reporting for herself.    A 52-years-old female patient received bnt162b2 (BNT162B2) dose 2, intramuscular, administered in Arm Left on 18Mar2021 (Batch/Lot Number: EN6207; Expiration Date: 30Jun2021) as single dose,  for covid-19 immunisation (Age at vaccination 52 years).  Medical history included rheumatoid arthritis , coagulopathy. On 25Feb2021 the patient received the first dose of BNT162B2.  Concomitant medications included adalimumab (HUMIRA) taken for rheumatoid arthritis from Jan2021 to an unspecified stop date.  The patient experienced  a rheumatoid arthritis flare up  on an unspecified date with outcome of unknown.  The vent was treated with steroids.  Course of the event.  After the first dose of the covid vaccine, she had no problems. She started having symptoms after the second dose of the covid vaccine.   Symptoms began about a week after receiving the second dose of the covid vaccine. She also had joint stiffness. Her rheumatoid arthritis was well controlled before taking the covid vaccine. The way  she is feeling now, she has never felt before. She can hardly work every day. Her doctor put her on Prednisone to ease up the pain and swelling. Her rheumatoid arthritis flare up is about the same. She thinks that it might be worse, because it goes from different joints to different joints. One day it might be her left and shoulder, and then the next day be her right hand and leg. Her doctor told her it was a rheumatoid arthritis flare up.  She is on Humira. After the second dose of the covid vaccine, she was supposed to take Humira. She did not take her Humira because of the symptoms she was experiencing from the covid vaccine.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the event rheumatoid arthritis flare up cannot be excluded. The event being part of the natural course of pre-existing RA cannot be excluded as well. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. 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. ,Linked Report(s) : US-PFIZER INC-2021499905 same patient/drug, different vaccine dose/AE
Approximately 1-2 minutes after sitting down after receiving shot, patient lost and regained consciousness. Patient then appeared extremely sweaty and dizzy. He did state he was nervous about receiving the vaccine before coming in and was slightly dehydrated. He also denied paramedic services.  I provided a space for patient to elevate his feet, an ice pack/wet towel and water. Patient then reported losing feeling in fingers and left arm. He denied having trouble breathing and was able to lift his arms.  After ~15 - 20 minutes, patient stated he felt fine. I had patient sit for an extra 15 minutes to ensure he was fine then patient left with his SO. A phone call will be made tomorrow to check in on patient.
C/O HA, dizziness, nausea, erythematous face on and off, face puffy under eyes. 50mg of Benadryl administered in the office and was some better after 1 hour. Pt called back the next day 8/21 stating they went to the ER and was given more Benadryl and a anti-nausea med.  Much better after second dose of Benadryl and anti-nausea med.
Hives located on chest,  right shoulder, back, and stomach.  Diphenhydramine 25 mg taken at 2pm and 11pm day of vaccination (1/25/21)
injection site pain, excessive menstrual flow (period onset day following immunization, on Mar 3, in the evening)
anxiety; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced anxiety just after the day of receiving the second dose of covid-19 vaccination. The patient believed the anxiety was due to vaccine as she never suffered from anxiety before the vaccine. It was unknown if therapeutic measures were taken for the events. It was unknown if patient received any other vaccines within 4 weeks prior and other medications 2 weeks prior to the COVID vaccine. It was unknown if patient tested positive for covid-19 prior to vaccination and unknown if tested post vaccination. The outcome of the event was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
1st dose 22Nov2021, 2nd not yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in unknown location on 22nd November 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 21-Nov-2022 Reporter's comment: The pharmacist asked that should restart the series. Did not consent to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
It itches; Suspected vaccination failure; Broke out now; Water blister on left hand, on finger; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (Family History) (shingles for daughter and niece).   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On 21st April 2022, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and blister. On an unknown date, the patient experienced pruritus. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, blister and pruritus were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, blister and pruritus to be related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 21-Apr-2022 Reporter's Comments: This case was reported by the patient. The patient was vaccinated in 2019 with both doses and had a blister on her left hand finger when waking up the morning of the day of reporting and wanted to know if she needed to be revaccinated, the patient described it was a water blister and it itched, only one blister so far but had been itching between all fingers on left hand. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding laboratory test confirming shingles were unknown at the time of reporting.
Expired Twinrix was administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 61-year-old male patient who received HAB (Twinrix) (batch number X239D, expiry date 7th August 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 23rd August 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 23rd August 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 23-Aug-2022 Reporter's comment: The health care professional reported that an expired Twinrix was administered on the day of reporting. No reactions were reported. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up via postal. Additional supportive information: The patient received an expired dose of Twinrix, which led to expired vaccine used.
pain, heat and swelling at injection site - as well as blisters and whelps around the site for about two inches all the way around
Pt stated her arm became swollen, painful and developed a knot above the administration site. The knot and pain is still there 4 weeks later. She is going to follow up with her healthcare provider
pt recvd vax 25MAR93; 3APR93-6APR93 rash from head to foot & temp 104 R; mom spoke w/MD on 6APR93 & told her not to worry a nl reaction to MMR; pt to MD on 8APR93 dx rubella;
Received unintended vaccinia vaccination on or about 2nd week of June 2004 from close contact with boyfriend in military.  Portion of scab sent to lab.  Pictures of lesion sent to CDC.
3/27/21 muscle aches, arm pain 9/10, fatigue. 10 days later injection site red, hot, swollen, rash.  14 days post vaccine arm pain and muscle spasms from arm to neck.  Neck pain currently three weeks post vaccine.
Pt presents with red raised, warm to touch area to left deltoid area. Pt received the pneumonia vaccine to this arm on Nov. 3. Pt states it has been sore ever since. Pt states the weekend after receiving both the pneumonia and flu vaccine at her visit on Nov. 3rd - she was ill over following weekend with chills/fever, but it resolved. However, the right arm has been sore since injection.
this is one of 4 individuals, out of 25 vaccines, to devel a red, hard knot @ the inj site following vax;
pt recv vax 8OCT98 & BP 164/88, dry mouth, lips felt like swelling, pale, felt light headed; 7:45 164/86;remained elevated for 3 wk;