chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable consumer. This is the second of two reports from a female consumer. A currently 4-month-old male was administered the second dose of PREVNAR 13 on his thigh for pneumonia and meningitis on 31Jan2011. Relevant medical history included bronchitis, fever, cough, and sickness on 07Dec2010, after administration of the first dose of PREVNAR 13, administered on 23Nov2010. Relevant concomitant medications were none. On 31Jan2011, the patient again experienced bronchitis, fever, cough and was sick. These events were considered medically significant. Relevant laboratory test results were not reported. At the time of the report the clinical outcome of the events was unknown.
sick; really high fevers; This is a spontaneous report from a contactable consumer (patient). This consumer reported for 3 reports. This is 3rd of 3 reports. A 28-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-119 VACCINE, Solution for injection, lot number: 046A21A) via unknown route of administration on 24Mar2021 as dose 1 single for COVID-19 immunisation. Medical history included COVID virus from Nov2020 (from her brother). Concomitant medication was not reported. It was reported that she was she was sick on 24Mar2021, only for the common 48-72 hours, she had really high fevers with both vaccine doses. With the first dose her fever started on 24Mar2021 and it has recovered completely at this point. She also got the COVID virus from her brother in November 2020. She says the fever with her first dose went away on the third day, so it went away 27Mar2021. The outcome of event fever was recovered on 27Mar2021, for other was unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021560177 similar report from same reporter
This case was reported by a healthcare professional (medical assistant), via another manufacturer (Merck), and described the occurrence of hepatitis B antibody negative in a male subject of unspecified age who was vaccinated with TWINRIX (GlaxoSmithKline). On an unspecified date the subject received 1st dose, 2nd dose and 3rd dose of TWINRIX (details unknown) and experienced hepatitis B antibody negative. The subject received three doses of TWINRIX on unspecified dates and "failed to seroconvert for Hepatitis B". No further information was available.
Swollen lymph nodes in neck and itching down left arm and upper torso on left side
Patient have rash few hours later and feel nausea and vomiting symptoms along with dull pain at the injection site and arm which is more pronounce on moving the arm. Rash resolved 3 to 4 days later but pain is still exising. Using advil to help the pain.
Pt felt nauseated and weak, sit down on floor. VS 90/50, R 16, P 64, Rev 10 minutes later 100/60 R 18 P 84.
The patient stated that following the vaccination, she experienced a "drilling" pain in her right arm that sometimes radiates down the arm.  She reported that the pain is approximately 2 inches below the shoulder.  She reported that she received her 2nd (4/28/21) and 3rd dose (8/19/2021) of COVID vaccine in the same arm and reported that the pain has continued and is not improving.  She reported that she went to her orthopedic doctor on 3/4/22 to assess and treat the pain in her knee and while there, she asked about her shoulder pain.  She reported that he took an Xray of the shoulder which did not itentify a problem and she reported that he was referring her for an MRI which is to be completed later this week.
shingles; This is a spontaneous report from a Pfizer sponsored program received from a contactable consumer. A female patient of an unspecified age received second dose of BNT162B2 (BNT162B2) via an unspecified route of administration on 23Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced shingles on an unspecified date. Outcome of the event was unknown.    No follow-up attempts are needed. No further information is expected.
Red circle on same side of injection; Arm started itching every now and then; A spontaneous report was received from a consumer concerning a 58-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events arm started itching every nowand then (vaccination site pruritus) and red circle on same side of injection (vaccination site erythema).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 27 Jan 2021, the patient received their first of the two planned doses of mRNA-1273 (Batch number: 004M20A) in the left arm for the prophylaxis of COVID-19 infection.  On 06 Feb 2021, reporter stated their arm started itching, and that there's a red circle on same side of injection. Describes symptoms as itching every now and then, not uncontrollably. Noticed round area around the site but it does not hurt, just itching.  Treatment information not provided. Lab tests not provided.  Action taken with response to mRNA-1273 was not reported.  The outcome of the event, arm started itching every now and then and red circle on same side of injection was considered unknown.
PATIENT LATER REPORTED THAT SHE FELT EXTREME HYPOTENSION, BUT HAD CHOSE NOT TO GO TO THE HOSPITAL. HAS SINCE RESOLVED.
punctured IPOL administered post excursion with no reported adverse event; Initial information received on 13-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to case 2022SA422364.  This case involves a 14 years old male patient to whom punctured IPV (VERO) [IPOL].administered post excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation; DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) for Immunisation; MENINGOCOCCAL VACCINE A/C/Y/W CONJ (TET TOX) (MENQUADFI) for Immunisation; and HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Immunisation.  On 03-Oct-2022, the patient received  0.5 ml (once) dose of suspect punctured IPV (VERO), Suspension for injection (lot V1A024M; expiry date 17-Feb-2024) via intramuscular route in the right deltoid for Immunization  post excursion with no reported adverse event (poor quality product administered) (latency: on same day).  Action taken :  not applicable.  Outcome : Unknown.   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 the 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.
Late and heavy menstruation. (I have never been late before) Brain fog Night time panic attacks Fatigue
Pediarix that had previously been frozen.; This case was reported by a pharmacist via sales rep and described the occurrence of incorrect product storage in a patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced incorrect product storage. On an unknown date, the outcome of the incorrect product storage 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 details were provided as follows: Age at vaccination was not reported. The pharmacist reported that the patient received dose of Pediarix that had previously been frozen, which led to incorrect product storage. The date of the dose, amount of dose, administration site, or which number dose within the series were not reported. The nurse that administered the dose stated that the dose had to be warmed up with her hands prior to administration, and the dose was thawed prior to administration.  The outcome of the patient receiving the dose of Pediarix was unknown. The reporter consented to follow up.
Vaccine given to me at  10:00 am on 05-04-2032 at the Volunteer  Fire Dept.  At approx 12:05 am 04-05-2021, I  woke up with every , EVERY. joint in my body on fire,  I  realized that it was a reaction  and took 2 aspirin  which did no good.  I  paced around crying til daylight and called the phone number my insurance makes you call.  Some woman told me to call my PCP office, which I did,  I went to the hospital here, they  just assumed I  was lying and wanted pain meds, even tho I did not ask for any, I  told them  I  thought it was attraction to the vaccine. I  got so bad in two more  days. Went back to hospital or urgent care again  Again they said I was drug seeking  They would not listen to me about my Multiple Heteditary Exostosis or MH Osteochrondromitosis. Even tho I  brought in 10 CD s plus paper reports saying how very severe my case is and how many opetations I ve  had, plus all of spine and neck is filled with stenosis and osteoarthritis. They wouldn't  look at my CDs from OHSU,  nor read any of the reports. I had to go to bed then a friend thought I was dying and took me up to OzJSU.
3rd anthrax vaccination at 0945 today welts and itching onset 1145 hrs. Spread over 30 min extending soles & palms to neck. No swelling, erythema or airway difficulty. Treatment IM Benadryl, transported to hospital.
Complete Swelling of the body, swelling wrapped around injection side, his arm was blown up. He was rushed to the emergency room where he was giving steriods and Benadryl.
2 year old male received care at Clinic on 14DEC2022. Received HEP-A #2 and Flu #2 . 48hours after, Parent of patient noticed Hives on his upper and lover legs and a low grade fever. Parents administer Ibuprofen (Unknown dose at this time) and applied petroleum based lotion with diaper changes. Contacted provider and had a virtual appointment on 21DEC2022 due to COVID-19 pandemic. Instructed to monitor the patients skin and to contact the clinic if new rashes appeared or reoccur. Symptoms lasted for 5 day.  Symptoms resolved on their own.
Throat started tightening g 1 and one half hour after shot given plus neck started burning.
Received TDaP and CPX vaccine on 8/14/13. On 8/16/13 broke out in rash with small blisters on top of R knee to ankle. No fever but does itch. All of calf rash, worse on knee. Applied hydrocortisone cream and benadryl cream. 9/3/13 till has some blisters, sore in certain areas. Still on R leg - has 3 spots (blisters) on L leg. Started applying Abreva and rash is drying.
1. Headache, fatigue, left arm soreness starting next day after vaccine lasting for 3 days 2. Rash on torso starting 2 days after vaccine lasting for 4 days
Pt received vaccine 10/28, on 11/2 pt came in stating starting 10/29 she felt overall body/muscle pain, HA and blisters on upper lip. She took 1 tab Ibuprofen each day. By 11/2 she had improvement and follow up on 11/4 she felt back to normal.
(YF & oral Typhoid 3-14-11) 3/21/11 reaction red & swelling arm and rash.
I received my vaccination approximately a year ago. About a month later, I started having some kind of fungal reaction on about 50% of my body (groin, buttocks, head, back, legs and arms). 4 different doctors, but none have been able to diagnose my condition.
On exam by the provider results were as follows:  face was somewhat flushed, little bit of patchy redness over her chest and neck area.  Oropharynx was clear, posterior  pharynx is minimally erythematous left posterior pharynx.   Patient reported itchy throat. These symptoms occurred 15 minutes after her COVID 19 injection was administered.  After being examined by Dr.  the order was given to administer Benadryl 25mg IM in the right deltoid.  This was administered by the CMA.
Child with 3hr prolonged crying episode. Started roughly 3hrs after getting vaccines. Resolved with warm compresses to the thighs.
Swollen and sore arm.  Rash over area of approximately 8 by 9 inches.  Very warm to touch.
Onset 0300, awoke with dizziness, nausea, numbness in fingertips to elbows. Also had a high heart rate with chest tightness, syncope, tremors.
Hives on face, Fatigue, Irritability, Fever (100.2) - Day 1. Extreme Hives all over body including sight of injection, cough, runny nose, low grade fever (99.3) - Day.
Fainting and vomiting after GARDASIL immunization. Dizziness and nausea lasted 1/4 hour.
Patient had redness and swelling around the site as well as itching. Patient stated that she had no reaction to the first dose only the second
SEVERE HEADACHE; LITTLE DIZZY; NECK WAS ITCHING AND BREAKING OUT/ RASH AND A BUMP ON HIS NECK; SORE ARM; This spontaneous report received from a parent concerned a 21 year old male. 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: 204A21A, and expiry: UNKNOWN) dose was not reported, administered on 16-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-AUG-2021, the patient experienced little dizzy. On 16-AUG-2021, the patient experienced neck was itching and breaking out/ rash and a bump on his neck. On 16-AUG-2021, the patient experienced sore arm. On 17-AUG-2021, the patient experienced severe headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe headache, little dizzy, and neck was itching and breaking out/ rash and a bump on his neck, and the outcome of sore arm was not reported. This report was non-serious.
Soreness in left armpit; This is a spontaneous report from a non-contactable consumer, the patient. A 42-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number- UNKNOWN) via an unspecified route of administration in the left arm on 10Mar2021 at 00:15 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The Patient did not have any allergies to medications, food, or other products. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient had not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced a feeling of soreness in the left armpit on 17Mar2021 at 16:00. It was reported with adverse event that patient having to take ibuprofen. The patient did not receive treatment for the reported event. . The clinical outcome of axillary pain was not recovered. Information about lot/batch number cannot be obtained. No further information is expected.
Subsequent to receiving one dose of varicella virus vaccine live the pt broke out in chickenpox with marks covering her torso with more on her legs and face. She was seen by the school nurse. The pts sister also had a similar experience.  No further information is available.
50 y/o female with DM, HTN, Hypothyroidism received PNEUMOVAX (SQ) and Flu (IM) in right arm on 10/12/10. She began to experience pain & swelling in that arm the same evening - pain was a 10/10. Wanted to go the ER-but did not & was seen in office on 10/13/10 -swelling & erythema over the area of SQ injection - hypersensitivity to the touch - treated with MOTRIN/KEFLEX/PERCOCET. Spoke with pt via phone 12hrs later & sx had almost fully resolved. This was pt's 2nd PNEUMOVAX by mistake. She had gotten PNEUMOVAX on 4/8/10. Prior Flu shot 9/15/2009 & H1N1 on 11/21/09.
Rash. Dr. treating her for impetigo with Keflex and Mupirocin.
I got the vaccine on Tuesday, on Wednesday night  In the middle of the night, I had extreme leg cramps, more severe than I have had before in both legs.  I got nauseous and vomited, not sure if due to pain or a reaction. I took potassium and drank more water the next day. Again, I Thursday nIght, I had another EXTREME episode. Felt my whole body was cramping.  It lasted about 5 to 10 minutes.  I drank a lot again, took several vitamins, potassium and one gabapentin on Friday night. I did not have an episode on Friday night. I am not sure if this is related to vaccine but felt the need to report as I suspect somehow my electrolytes were affected.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 02-NOV-2015, the patient was vaccinated with 3rd dose of improperly stored GARDASIL ith lot number: K016966, expiry date: 10-MAY-2-017 (dose and strength unspecified). No concomitant medications were reported. No adverse effect were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Pt developed mild rash on legs, fever first 2 days of rash which started 11 days post vaccination.
2nd dose has not been administered yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 75-year-old female patient who received HAB (Twinrix adult) for prophylaxis.   Previously administered products included Twinrix adult (On 23rd January 2023, the first dose was received).   On an unknown date, the patient received the 2nd dose of Twinrix adult. On an unknown date, an unknown time after receiving Twinrix adult, the patient experienced incomplete course of vaccination (Verbatim: 2nd dose has not been administered yet). The outcome of the incomplete course of vaccination 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-MAR-2023 The pharmacist called to inquire on how to proceed and go about the schedule with Twinrix series. The patient received a Twinrix first dose 2 months ago and would like to get the second dose. The reporter confirmed the second dose had not been administered yet. The reporter did not consent to follow up. Till the time of reporting, the patient did not receive 2nd dose of Twinrix, which led to incomplete course of vaccination.
Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: Patient felt okay no symptoms but injection site swole up and had a bubble around it. the injection site was red and swollen. Patient waited 15 min and was given an ice pack. the swelling was reduced but still a bump at injection site. patient felt fine no different then before and went home after 15 minutes.
Within 15 minutes got cold hands & feet, tremors throughout body,  lightheaded/dizzy, all over weakness. Stayed at location of vaccine for 2.5 hours and laid down and they monitored my BP, HR, Pulse Oximetry & then went to Urgent Care.
Patient was getting ready to leave the office when she fainted and vomited.  No tonic-clonic activity.  No increase in heart rate felt.  She laid down and felt fine 5 minutes later.
Healthy 36 year old adult with no prior symptoms suddenly collapsed and suffered a Tonic Clonic Seizure (Grand Mal Seizure)  lasting about 11 minutes.
Asthma; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 11 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 11 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ASTHMA (non-serious), outcome "unknown", described as "Asthma". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: What happens with the kids that were part of the clinical trial when it has been 6 months after their last dose, Caller agreed to transfer to, but disconnected during hold. E-transmitting possible duplicate AE info. Consumer states that here 11 year old son was participating in the Pfizer clinical trials for the COVID 19 vaccine. It has been more than 6 months since his last dose. We did an antibody test and his levels are declining. He has asthma. Response was received that Per VR, referred caller to the clinical trial investigator that they have been working with. No information at . The reporter stating the events as non serious.  The lot number for bnt162b2 was not provided and will be requested during follow up.
intense body aches, chills, weird smell from skin, fatigue; on day 2, I developed a persistent, dry, hacking cough that lasted 5 weeks; I strained (?) a rib during the 2nd or 3rd week from coughing so much; my chronic inhaler nor my emergency inhaler relieved the coughing. I also tried allergy pills which didn't relieve the coughing either
Information has been received from a registered nurse concerning a 25 year old female with drug reaction/allergy to amoxicillin/clavulanate potassium (AUGMENTIN) and codeine, and a history of tonsillectomy who on 23-OCT-2007 was vaccinated subcutaneously, "back of right arm" with the first 0.5 mL dose of Pneumovax 23, (Lot # 656233/0200U). Concomitantly, the patient was vaccinated into the opposite arm with influenza virus vaccine (unspecified). The nurse reported that the patient was hospitalized either late 24-OCT-2007 or early in the morning on 25-OCT-2007 because of cellulitis and infection on one of her arms. This was the patient's first dose of Pneumovax 23. The area was lanced and the patient was still in the hospital. The nurse did not know which arm was affected. The nurse requested a lot check for Pneumovax 23, (Lot # 656233/0200U). At the time of the report, it was unknown if the patient recovered. Additional information has been requested.