chrisvoncsefalvay/vaers-outcomes huggingface dataset:
CONFIRMED IMMUNUNOLOGICAL VACCINATION FAILURE; CHEST PAIN TOWARDS THE LEFT; LEFT SHOULDER PAIN/ PROLONGED JOINT ACHES; FATIGUE; This spontaneous report received from a patient concerned a 45 year old female. The patient's weight was 133 pounds, and height was 66 centimeters. The patient's concurrent conditions included alcohol use (occasional glass of wine), and non-smoker. The patient was not pregnant at the time of reporting. The patient had no known allergies/no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A and expiry: 21-JUN-2021) dose was not reported, 1 total administered in left arm on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 06-MAY-2021, the subject experienced confirmed immunological vaccination failure. On 08-APR-2021, the patient experienced left shoulder pain/ prolonged joint aches, chest pain towards the left, and fatigue. On 06-MAY-2021 laboratory data included: C-reactive protein (NR: not provided) normal, CPK (NR: not provided) normal, Electrocardiogram (NR: not provided) normal, Erythrocyte sedimentation rate (NR: not provided) normal, Fibrin D dimer (NR: not provided) normal, and SARS-CoV-2 antibody test (NR: not provided) less than 1 which was negative. On 08-MAY-2021, the patient recovered from prolonged joint aches. The patient had an emergency room visit for left shoulder pain and chest pain towards the left. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue on 29-APR-2021, was recovering from chest pain towards the left, had not recovered from left shoulder pain, and the outcome of confirmed immunological vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210519849-covid-19 vaccine ad26.cov2.s- confirmed immunological vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS 20210519849-covid-19 vaccine ad26.cov2.s-  left shoulder pain/ prolonged joint aches, fatigue. This event(s) is labeled per RSI and is therefore considered potentially related.
Dizziness, Headache, Myalgia, NauseaVomiting, 1st dose: arm pain, fatigue and spent 3 days in bed, chills  Narrative:
During 15 minute observation period after administration of Moderna vaccine, patient reported feeling dizzy and nauseous. Patient was transferred into wheelchair and brought into an examination room with provider NP. Provider and staff collected vitals, blood sugars, and HPI. Patient reported he "felt like he was going to pass out" but did not actually syncopize. Patient was with staff for well over one hour for observation, and symptoms resolved within 15 minutes of the initial onset without intervention. It was deemed likely vasovagal response by the provider.
31 hours after receiving the Pfizer vaccine I experienced severe abdominal cramping, bloating, gas, nausea, & diarrhea. The more severe symptoms started right before 6:30pm and lasted until after midnight. At this time (>48 hrs after vaccine) there is still slight cramping.
Severe pain when trying to move the arm under it's own power, especially laterally. Almost painless when the arm is just resting on the side.
injection site pain, injection arm was very sore, headache, muscle aches - opposite side of arm that was site of injection, legs, neck & shoulders, lower back (aches kind of came and went), mild nausea, mild diarrhea, fatigue, temporary loss of appetite.  No treatment was necessary, all symptoms are mild to medium and flu-like.
Food poisoning; vomited three times; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 85 year-old female patient received bnt162b2 (BNT162B2), administration date Mar2021 (Lot number: EN6201) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FOOD POISONING (non-serious), outcome "unknown", described as "Food poisoning"; VOMITING (non-serious), outcome "unknown", described as "vomited three times".  Additional information: Reporter was calling on behalf of her mother who was 85 years old. Patient had the Pfizer vaccine on Mar2021, sometime 10Mar, not 10Mar2021 earlier, but patient had a scheduled appointment today to do the second dose. But then yesterday, patient had food poisoning and she has vomited three times. Reporter asked if patient can take the vaccine or not.  No follow-up attempts are possible. No further information is expected.
Pt developed redness, swelling, tenderness, at site as well as fever (he didn't measure) stiff neck, headache, redness at axilla left upper arm at swollen lymph nodes.
Next day on 12/23/2022 to booster shot, I felt huge irritable body pain (specially muscle pain), back pain, knee pain, headache, burning eyes, felt bad head/inflammation in body - specially in foot and palms but at the same time feeling badly cold (shivering), fever, low body energy, bad or bitter mouth taste like I cannot feel the taste of food. Got my monthly mensuration cycles early by a week which were really worst. I felt these mentioned symptoms for 10days and then I get back to normal. Strange thing after 1 month I am seeing the all same symptoms again but with half less worst to what I faced for 10days after 12/23/2022.
Patient has had a fever and flu like symptoms for over 3 days; Patient has had a fever and flu like symptoms for over 3 days; This is a spontaneous report from a non-contactable other healthcare professional, the patient.  A 51-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot number: Ek5730, via intramuscular, on 18Dec2020 at 09:15 (at the age of 51 years old) as a single dose in the left arm for COVID-19 vaccination.  Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included other vaccine (not specified) on 03Dec2020. The vaccine was given at a hospital. On Dec2020,  the patient experienced had a fever and flu like symptoms for over 3 days. The event resulted in emergency room visit. No treatment was received for had a fever and flu like symptoms for over 3 days. The clinical outcome of had a fever and flu like symptoms for over 3 days was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Both legs started going numb a few days later. Numbness has been gradually ascending. About that same time noted her hands felt numb and her arms feel heavy. Legs started to hurt after a few more days from about the knee level down. Having trouble with weakness in legs. Able to walk for short distances.
pt was directed to sit outside for 15 minutes after vaccines  after covid Pfizer was administered . RPH heard parent screaming in waiting area and saw pt lethargic and in parent arms , kind of limp. rph called 911 and asked pharmacy staff to call 911 while staying on the phone with 911 operator . rph asked pt how she is feeling and she said ok but she was covered in profuse sweat . took winter jacket off upon removing jacket pt seemed better . the EMT arrived and took pt outside of waiting area . tried to contact parents as follow up but had no response
pneumonia; She had a big, red and swollen spot on her arm and a fever of 100 degrees / was at the injection site only, she had a red the size of baseball and it was hot and had a fever of 100 degrees; She had a big, red and swollen spot on her arm and a fever of 100 degrees / was at the injection site only, she had a red the size of baseball and it was hot and had a fever of 100 degrees; She had a big, red and swollen spot on her arm and a fever of 100 degrees / was at the injection site only, she had a red the size of baseball and it was hot and had a fever of 100 degrees; She had a big, red and swollen spot on her arm and a fever of 100 degrees / was at the injection site only, she had a red the size of baseball and it was hot and had a fever of 100 degrees; This spontaneous report was received from a currently 68-year-old female patient referring to herself. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On an unreported date in 2014, the patient received her first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, route of administration, lot# and expiration date were not provided) for prophylaxis.  On an unreported date in 2014, the patient had a reaction to the vaccine - it was at the injection site only, she had a red the size of baseball and it was hot and had a fever of 100 degrees (unspecified). The patient reported this to FDA and FDA thought it was due to the preservative in the dose. On an unreported date, the patient had pneumonia (no details provided). On an unreported date in 2020, the patient received the second dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, route of administration, lot# and expiration date were not provided; for prophylaxis) and had no reaction. The outcome of the events was not provided. The reporter considered vaccination site erythema, pyrexia, vaccination site warmth and vaccination site swelling to be related to Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23). The causality assessment between the suspect and pneumonia was not provided.  Upon internal review, the event pneumonia was considered to be medically significant.
Body chills, sweating, body aches, nausea, cramps, diarrhea, no appetite
Information has been received from a health professional concerning a 68 year old female patient who was vaccinated with series of RECOMBIVAX HB from September 1998 to April 1999. Blood work was obtained on 19-DEC-2009 and results obtained on 23-DEC-2009 were "not immune". At the time of the report the status of the patient was unspecified. It was unspecified if the patient sought medical attention. Follow up information has been received from a health professional who reported that the patient would be given again the series of 3 shots of RECOMBIVAX HB and probably in the summer (July 2010 or August 2010). The patient would be sent for testing to make sure immunity took. This is one of several reports received from the same source. Additional information has been requested.
Pt was given 2 injections on left upper Delt. Pt noticed swelling the AM on left arm lower interior part of arm- Swollen hot to touch about 3 inches.
Cellulitis; arm was painful; COVID arm; raised bumps; hives; little bit of swelling / arm was very swollen; This spontaneous case was reported by a consumer and describes the occurrence of CELLULITIS (Cellulitis) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, the patient experienced VACCINATION SITE REACTION (COVID arm), VACCINATION SITE MASS (raised bumps), VACCINATION SITE URTICARIA (hives) and VACCINATION SITE SWELLING (little bit of swelling / arm was very swollen). On 02-May-2021, the patient experienced CELLULITIS (Cellulitis) (seriousness criterion medically significant) and VACCINATION SITE PAIN (arm was painful). At the time of the report, CELLULITIS (Cellulitis), VACCINATION SITE REACTION (COVID arm), VACCINATION SITE MASS (raised bumps), VACCINATION SITE URTICARIA (hives), VACCINATION SITE SWELLING (little bit of swelling / arm was very swollen) and VACCINATION SITE PAIN (arm was painful) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported. Treatment included antibiotics. As per reporter, the patient has not yet started therapy, at the time of report.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Case previously recorded as MA2009-4029. Initial case report received from a physician via MedCom, on 05 NOV 2009. A 33 year-old female patient was vaccinated during pregnancy with 0.5 mL of S-OIV FLUVIRIN (batch no. 100738) i.m. on 03 NOV 2009. No adverse events were reported. MedCom reference no.: NA09-007596.
Had fever, headache, nasal congestion, had trouble sleeping, sore throat. I had not had the flu for 21 years prior to this event.
angina on june 25 followed by chest pain, on and off, for a month (ongoing).
Information has been received from a consumer concerning his 6 year old son who on an unknown dates was vaccinated with both doses of MMR II. After getting the second dose of MMR II, the patient changed his behavior. No further information is available.
03/30/2021 Vaccination. About 6-8 hours later, I just started feeling lousy, flu-like symptoms. Malaise. This lasted for 4 days. The 2nd or 3rd day, I don't even remember the day (stayed in bed).
Patient given 2 month vaccines at 10:15 am. After vaccines given patient's both legs from thigh to ankle were red, swollen slightly and warm. As per MD cool towel applied which child didn't seem to like. After 20 minutes everything subsided. Vital signs T-99.0. HR - 140 O2 - 100%.
Initial information received on 14-Aug-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 64 years old female patient who received expired vaccine RABIES (HDC) VACCINE. The patient's past medical history and family history were not provided.  The patient did not receive any concomitant medication. On 14-Aug-2018, the patient received a second dose of pre-exposure series of suspect RABIES (HDC) VACCINE lot M1296, expiry date 12 Jun 2018 via unknown route in the left deltoid. It was an actual medication error due to expired vaccine used. It was reported that patient was given expired rabies vaccine on 14 Aug 2018 that got expired on 12 Jun 2018. The patient did not experience any symptoms or need for treatment. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.
Patient received second pfizer vaccination at 13:01 and ambulated to the observation area unassisted. At 13:14 she stated she was feeling dizzy. VS: 89 bpm, 98%RA, 112/89, RR 14 non labored. Patient has (DM1, Graves Disease, Asthma, Autism) per mother. Patient has electronic glucose monitor and pump, Mother insists this is functioning as site was changed and inspected yesterday.   BS per monitor reading 331. EMS with patient and she was moved to inversion chair via wheel chair. When asked how she felt patient shook her head no in response.  Per mother patient most likely would not give more information because of her Autism. Patient given a water and demonstrated the ability to drink. When asked more specifically the patient denied nausea but admitted to still feeling dizzy and tired.  Patient is awake, pink, warm and dry, alert but mother states this is not her baseline cognitively. A brief period intermittent audible grunting noticed but then resolved on its own, breathing non labored and even. Patient holding and checking her phone periodically. Two episodes of patient closing her eye observed not lasting more than 2 seconds. Mother states patient has "uncontrolled epilepsy". Denies any itching or throat discomfort but is now stating she has chest pain. Patient unable to describe the pain to the RN. HR manually 98 bpm.  Skin remains warm, pink and dry, Alert.  VS: 99%, RR 16 non labored, 100 bpm, 108/65, Mom states she would feel more comfortable if patient went to hospital  "to be checked out and given fluids".   At 1342 patient transported to Medical Center via ambulance with Grandmother.
Hives, raised rash, non-pustular to bilateral arms. After 1 week still have some nodules remaim on upper left arm near the injection site.
This case was reported by a nurse via call center representative and described the occurrence of burning in eyes in a 56-year-old female nurse who intended to vaccinate with SHINGRIX (batch number AC5GX, expiry date 8th March 2021) for prophylaxis. On 23rd October 2018, the patient received SHINGRIX. On 23rd October 2018, unknown after receiving SHINGRIX, the patient experienced inadvertent exposure to vaccine and exposure via eye contact. On an unknown date, the outcome of the inadvertent exposure to vaccine and exposure via eye contact were unknown. Additional details were provided as follows: The age at vaccination was not applicable for this report. The healthcare professional stated that an employee inadvertently got SHINGRIX in their eye while re-constituting the SHINGRIX vaccine, which led to inadvertent exposure to vaccine and exposure via eye contact. No further information provided by healthcare professional. Follow up information received from nurse (patient) on 21st December 2018: The reporter details were updated. The patient's demographic details were updated. The reporter added the diluent to powder. Some of the liquid went into the vial. The reporter tried to inject the liquid back into the vial. As reporter did, she guess the needle slipped out the SHINGRIX and sprayed in her eyes. Less than a year, after inadvertent exposure to SHINGRIX, the patient's eyes burned and turned red. The VAERS details were updated.
This spontaneous report was received from an office manager and refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical histories, drug reactions or allergies and concomitant medications were not reported. On unknown dates approximately in November 2016, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 injection, lot # L048680, expiration date 10-JUN-2017 (dose, route and site of administration were not reported). No adverse effects were reported. Product quality complaint was not involved. The administered doses of PNEUMOVAX 23 were stored in the temperature of 47.7 degrees Fahrenheit for 45 minutes on 18-NOV-2016, then in the temperature of 47.5 degrees Fahrenheit for 15 minutes, in the temperature of 48.4 degrees Fahrenheit for 30 minutes and in the temperature of 31.6 degrees Fahrenheit for 5.5 hours (1 cycle) on 19-NOV-2016, then in the temperature of 29.7 degrees Fahrenheit for 11 hours (1 cycle) and in the temperature of 33.4 degrees Fahrenheit for 15 minutes (1 cycle) on 20-NOV-2016. Data logger was involved. There were no previous temperature excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pt was observed for 30 min after administration of Moderna vaccine. No adverse reaction noted or reported.
Information has been received from a physician concerning a 17 year old female who was vaccinated with the first dose of the Gardasil on an unspecified date. The patient started to feel lightheaded immediately after receiving the Gardasil. At the time of the report, the patient was recovering. The patient did not wish to continue the vaccination series. Additional information has been requested.
1" 3/4" oval rash around site of MMRV with low grade fever.
lump; redness; pain; fatigue; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 77-year-old female patient who received Herpes zoster (Shingrix) (batch number Y2D94, expiry date 21st September 2021) for prophylaxis.   On 2nd August 2019, the patient received Shingrix (intramuscular) .5 ml. On 3rd August 2019, 1 days after receiving Shingrix, the patient experienced pain in arm, fatigue and erythema of extremities. On 5th August 2019, the patient experienced mass. On an unknown date, the outcome of the pain in arm and erythema of extremities were recovering/resolving and the outcome of the fatigue was recovered/resolved and the outcome of the mass was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, fatigue and erythema of extremities to be related to Shingrix. The reporter considered the mass to be probably related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on left deltoid. The next day of vaccination the patients arm was red and painful, but nothing terrible and she felt very fatigued for 2 days. The fatigue had resolved and her arm was less painful and only a little red. The day before reporting she noticed a lump under her clavicle. She happened to be at her dermatologist's office, so she had her dermatologist look. Her dermatologist said the lump was probably due to Shingrix and to wait a month and see what happens. The reporter gave consent to follow up. Emergency room visit required.
Anorexia; sudden fever = 24 hours later = 102-103. Vomiting x 2 and arm soreness.
Ringing in both ears following 2nd Anthrax shot. Ringing in the ears is constant. This problem began 1 week, post vax.
having a bunch of issues/stomach issues; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team, Program ID: (RA). The reporter is the parent.  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GASTRIC DISORDER (non-serious), outcome "unknown", described as "having a bunch of issues/stomach issues". Additional information: Nurse stated that her daughter is having a bunch of issues/stomach issues herself. Said it was Pfizer shot.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
"Serum sickness" 2. liters normal saline seen in ED - @ 1:12 AM 9/15/09 - Treated with TYLENOT, MOTRIN, SOLUMEDROL, BENADRYL IV.
HIVES ON THE ABDOMEN AND EXTREMITIES (ARM) PATIENT WAS GIVEN DIPHENHYDRAMINE 8ML (1520)
Pt. received flu vaccine 9/18/10. Started to notice pain (R) deltoid 9/25/10. Also pain in (R) shoulder.