chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ELBOW SWELLED LIKE GRAPEFRUIT; JOINTS WERE HUGE (KNEES AND ELBOWS WERE BIGGER THAN WHAT THEY SHOULD BE); SICKNESS; COVID-19; This spontaneous report received from a patient concerned a 64 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known allergies. no relevant medical history. The patient received covid-19 vaccine  (suspension for injection, intramuscular, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for drug used for unknown indication. No concomitant medications were reported. On 24-DEC-2020, the subject experienced covid-19. On an unspecified date, the subject experienced elbow swelled like grapefruit, joints were huge (knees and elbows were bigger than what they should be), and sickness. The action taken with covid-19 vaccine  was not applicable. The outcome of the elbow swelled like grapefruit, joints were huge (knees and elbows were bigger than what they should be), sickness and covid-19 was not reported. This report was non-serious.
Sore arm; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a male patient of an unspecified age received BNT162B2 (BNT162B2, PFIZER-BIONTECH, Covid-19 vaccine, solution for injection, Lot number and expiration date: Not reported), via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE, dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number and expiration date: was not reported) as DOSE 1 SINGLE both for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient experienced sore arm. The outcome of the event was unknown.  Follow-up attempts completed. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021184095 Same reporter, drug, event/different patient
15NOV cold/flu sx; 17NOV fainted x 2; eval by MD;
hives after the injection last friday; Initial information received on 03-Nov-2023 regarding an unsolicited valid non-serious case received from a Non-Healthcare Professional.  This case involves a 11 years old male patient who experienced hives after the injection last friday after receiving meningococcal a-c-y-w135 (t conj) vaccine [Menquadfi].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included influenza vaccine (Flu vaccine VII) and diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) for Prophylactic vaccination.  On 27-Oct-2023, the patient received a dose of suspect meningococcal a-c-y-w135 (t conj) vaccine Solution for injection lot number not reported via intramuscular route in the arm nos (dose, strength and expiration date: not provided) for Immunisation.  On an unknown date the patient developed hives after the injection last friday (urticaria) (unknown latency) following the administration of meningococcal a-c-y-w135 (t conj) vaccine.  Action taken- not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event hives.
Circular bruise on the injection site. Started as big, hard lump, painful to touch for 1 week. Hard lump resolved after 2 weeks but still has residual black bruise up after almost 4 weeks. Will be getting my 2nd dose tomorrow after 4 weeks initial shot.
Patient c/o light headedness, diaphoresis, and sweating shortly after receiving vaccine. Symptom onset ~1145a, vaccine time ~1140am. She was incontinent of urine. No loss of consciousness. Neuro intact entire time - no seizure activity. No facial swelling, difficulty breathing, rash. No chest pain. She did complain of left trapezius pain. All extremities with normal movement. Patient was laid flat on cot - no injury sustained.  15L O2 NRB placed.Vitals: 1150: 116/50, HR: 51, Spo2 99%, 1155: 115/65, HR 62, 97%. Blood glucsoe: 110 mg/dl. ECG SR. Patient did feel better once laying flat.    911 was called at symptom onset. EMS arrived at 12:05p. Reports provided. Patient transported to  Hospital ER.
Complained of itching all over. Rash noted arms, face, inner legs and buttocks. BENADRYL 25mg given PO. DECADRON 4mg with Depomedral 40mg IM. Pruritis improving released to husband. Use BENADRYL PRN. Itching legs, rash continues.
presented to ED with weakness and hyperkalemia; admitted to hospital; positive COVID test on 8/24; bilat air space disease, condition declined
1.5cm X 10.5cm of Erythema and induration on right. Local reaction.
Client came in to receive his scheduled second vaccination.  On the top right hand corner of this client?s questionnaire was written, ?2nd dose of Moderna? by staff, after she had asked patient what vaccination he had received.   Client is Spanish-speaking; whereas English is not his primary  language.     Client was seated at the Moderna table, where paramedic was registering client in EPIC Rover and other paramedic was to vaccinate.  Client told this nurse that he had placed his Covid-19 vaccination card on the table prior to being vaccinated.   Staff proceeded to vaccinate patient with the Moderna vaccine.  When nurse went to stamp this client?s Covid-19 vaccination card, it was then that she realized that Moderna should not have been given.  Immediately, nurse notified this nurse of the medication error.    This nurse went to assess the client for any unusual symptoms or reactions to the Moderna vaccine. Patient verbalized that he felt fine.  This nurse then informed the client that he had mistakenly been given the  Moderna vaccine instead of the Pfizer vaccine.  Nurse was then notified of the incident and spoke to the client in Spanish regarding his concerns.   Client was told to go to the nearest Emergency room if he developed any unusual symptoms.  Client verbalized understanding.   This nurse also reached out to inform her of the aforementioned incide
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were no provided. On 29-JAN-2019,  the patient was inadvertently vaccinated with M-M-R II intramuscularly (incorrect route of product administration) lot # R000556,  expiration date on 08-JAN-2020, for prophylaxis (strength, dosage and frequency were not provided).
Patient presented to the ED with SOA that started several days prior and was worsening. He was exposed to someone with COVID at his nursing home an tested positive here.  He is still inpatient.
Fever slowly moving from 100.4 to 101.9 over the course of a few hours. Shivers with it. My temp is usually 96.8 not 98.6 so this was a high fever for me.
Injection site gotten bigger, pinkish, kind of a rash but not really a rash; diarrhea; low grade fever; This spontaneous case was reported by a patient and describes the occurrence of DIARRHOEA (diarrhea), PYREXIA (low grade fever) and VACCINATION SITE RASH (Injection site gotten bigger, pinkish, kind of a rash but not really a rash) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 030A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction (No reported medical history).   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced DIARRHOEA (diarrhea) and PYREXIA (low grade fever). On an unknown date, the patient experienced VACCINATION SITE RASH (Injection site gotten bigger, pinkish, kind of a rash but not really a rash). At the time of the report, DIARRHOEA (diarrhea), PYREXIA (low grade fever) and VACCINATION SITE RASH (Injection site gotten bigger, pinkish, kind of a rash but not really a rash) outcome was unknown.            No concomitant information was reported. Treatment information was not reported.   This case was linked to MOD-2021-034765 (Patient Link).
Shortness of breath; Sore throat; Headache; Runny nose; This is a spontaneous report from a contactable consumer (patient) reported for herself.  A 46-year-old female patient received the first dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: EW0168) via an intramuscular route of administration at deltoid right on 21May2021 as 1st dose, single dose (at the age of 46-year-old) for COVID-19 immunization. The NDC number of Pfizer COVID vaccine was unknown. Patient's medical history included asthma, bruit in carotid artery, mitral valve pro lapse (diagnosed years before), chronic bronchitis and demyelinating disease of the central nervous system (CNS). She did not take any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient's concomitant medications were not reported. It was reported that post vaccination of 1st dose on an unspecified date (24May2021 or 25May2021), patient experienced shortness of breath, sore throat, headache and runny nose. In line with the side effects, she experienced after her 1st dose, she would like to seek recommendation in regards getting her 2nd dose. It was reported that she experienced body aches anyway from her condition and did not think it was related. She got Chronic Bronchitis every year but she did not get it this year. It was reported that she did not went for the doctor. No one can get her in until next week, which was when she was going to her ENT. She was going to ENT because she was pretty sure she has an ear infection. She is not sure if it was relevant to the shot or not. The other symptoms just happened not long ago. It was reported that, events was not-resolved.  No further details provided.  Follow up#1(PRD 11Jun2021): This is a follow-up spontaneous report from a Pfizer sponsored program COVAX US support. A contactable 46-year-old female consumer (patient) reported for herself that: (She provided start date for all of her symptoms as either 24May2021 or 25May2021, which would have been 2-3 days after getting the first dose. She thought they would go away but they have not. All her other medications she has been taking for 17-18 years.  No further details provided. She did not go to the doctor.  No one can get her in until next week, which is when she is going to her ENT.  She is going to because she is pretty sure she has an ear infection.  She is not sure if it is relevant to the shot or not.)   No further details provided. Information on Lot/Batch number was available.
Evening following injection and next day:  Mild headache was treated with acetaminophen.   Slightly chilled. Next day:  fatiqued.
Flu like symptoms; Fever of 103; This is a spontaneous report from a contactable consumer via the Medical Information Team. A patient of unspecified age and gender received BNT162B2 (COMIRNATY; solution for injection), via an unspecified route of administration on an unspecified date (lot number was not reported) as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter denied having flu like symptoms following the vaccine like others she has heard about. She (reporter) speaks of someone (patient) who had a fever of 103 that resolved after 1-2 days. The outcome of the events was recovered on an unspecified date.
Patient came in around 9AM for 2nd booster dose and stated that symptoms 2PM on the same day. Patient has not been able to eat anything since vaccine administration on 8/22/22. Patient also states that she's hot flashes/chills, N/V, diarrhea (within minutes of eating), constant HA since administration, skin hurts to the touch, muscle aches. Patient has used heating pad, shower, pushing fluids (water, tea), APAP.
I had a sore arm for about a day after receiving the vaccine. I had no symptoms prior to testing positive for COVID-19 on 02/16/2023. By the time I found out I had COVID-19, I was feeling better and did not require a prescription. As of today, I continue to sinus pressure and runny nose. I had a telehealth visit with my provider and was prescribed an antibiotic and a steroid for a sinusitis and bronchitis.
Severe Headache, Muscle pain, Weakness, Fever 102 for approximate 24 hours
Fever T max 102.6, redness and swelling at injection site. Pt given BACTRIM 200-4-5 1tsp PO BID x 10 days, Rifampin susp. 75/5 1 tsp PO BID x 10 days.
Had very mild Flu-like symptoms post 1st injection 3 months ago. General malaise, diffuse myalgia, anorexia w/o V/D. Mild nausea, & slight HA. SAME symptoms, but much more intense so much that I did not even want to walk outside.
received covid vaccine 12/30 then had rash on r side of face little shooting headache muscle weakeness on 12/31 11:00 am notices pins needles on left side of face.  Resolved then at 5 pm it came back again for a few hours then went away.  Then 1/1/21 left forhead tingling above eyebrow.  Today feels a little stiffness on the side of my face.   Also reported left ear hot and painful 12/31 at 11:00
Papular (raised) rash in crops over the antero-medical aspect of left thigh no erythema.
Initial report received on 23 January 2013 from another manufacturer who had received the original report from nurse. A 6-month old male patient experienced a systemic reaction of seizure 2 days after receiving a 3rd dose of ACTHIB vaccination (also reported as DTP vaccine) on 06 October 1999 (lot number 0970100, which is an invalid lot number for ACTHIB). Immunization series was discontinued. Information regarding other vaccines given the same day were unknown. The event was reported as not being life threatening, but the patient was hospitalized. It was thought the seizure was due to the pertussis containing vaccination. The outcome was resolved. Concomitant medications, relevant medical history, and adverse events with prior vaccinations were unknown. The patient subsequently received a dose of BOOSTRIX vaccine (GlaxoSmithKline) on 15 January 2013, which was the first pertussis containing vaccine the patient had received since the seizure in 1999. It was noted the patient weighed 13 pounds at 3 months of age. Documents held by sender: None.
generalized aching; COVID-19; fatigue; headache; This spontaneous case was reported by a physician and describes the occurrence of PAIN (generalized aching), COVID-19 (COVID-19), FATIGUE (fatigue) and HEADACHE (headache) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (moderate to severe).   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced PAIN (generalized aching), COVID-19 (COVID-19), FATIGUE (fatigue) and HEADACHE (headache). At the time of the report, PAIN (generalized aching), COVID-19 (COVID-19), FATIGUE (fatigue) and HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Follow-up information received on 24-05-2021 contains non-significant information.
She got the first rash nine days after the shot.  This rash was little pin prick size bumps.  Twelve days after the shot she became extremely irritable and at times hysterical.  She complained the following day of a headache and she was sleeping longer for naps and at night.  On day 13 she developed another type of rash that looked about the size of mosquito bites (they were not bites) on her legs.  Her terrible humor continued and she at times would hit her head against the floor.  On day fourteen she had an appointment with her gastro doctor and he was concerned and wanted to make sure we had called our pediatrician as she had fallen asleep in my arms at 10:30 in the morning and had been quite unconsolable prior to falling asleep, which was not her typical behavior at the gastro doctor.  By the afternoon of the 14th day she began to improve and continued over the next three days to have marked improvement until she was back to herself.  The only treatment she received was tylonal.
dose from vial that was opened on 6/18/21 was administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose from vial that was opened on 6/18/21 was administered) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose from vial that was opened on 6/18/21 was administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose from vial that was opened on 6/18/21 was administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided. No treatment details were provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Follow up received on 22-JUN-2021 contains patient demographics and event information.
Child had fever in early AM.  Resolved w/ tylenol.  Later that day, fever returned, she had an episode of diarrhea and crying so that she could not be consoled.  She was evaluated in the doctor's office 8/20.  She continued to have spells of crying and low grade fever for the next 2 days, gradually resolving.
Information has been received from a female pharmacist in her early 60's with a history of having a "strong reaction to medications" who on 12-FEB-2007 was vaccinated SC in the left arm with a dose of Zostavax. On approximately 12-FEB-2007 the patient developed a significant raised red area at the injection site that lasted 3-5 days, she also experienced radiation pain in the left arm going all the way to her chest area. The patient also developed flu like symptoms for 24 hours after receiving the vaccine. Unspecified medical attention was sought. Subsequently the patient recovered. There was no product quality complaint involved. No further information was provided. Additional information has been requested. Information has been received from a 55 year old female pharmacist with a history of having a "strong reaction to medciations" who on 29-JAN-2007 at 13:30 was vaccinated IM in the left arm with a first dose of ZOSTAVAX (Oka/Merck). There was no illness at the time of vaccination. On 29-JAN-2007 at 18:30 the patient developed a significant raised red area at the injection site that lasted 3-5 days. She also experienced radiating pain in the left arm going all the way to her chest area. The patient developed flu like symptoms for 24 hours after receiving the vaccine. Unspecified medical attention was sought. Subsequently the patient recovered. There was no product quality complaint involved. No further information was provided. Follow up information received from the patient indicated that she developed swelling and redness at the injection site. The area was reported to be round and about the size of a silver dollar. The iste stuck out about 1 inch. She was treated with BENADRYL and TYLENOL for 4 days. The patient's swelling and color was normal within 8 days. It was also noted that on 30-JAN-2007 the patient developed pain which radiated to her chest and shoulder blade. The patient recovered on 07-FEB-2007. The patient had no adverse events following prior vaccination/. Additional information is not expected.
Day 7: swollen lymph node in left armpit. Day 8-10: headache fever, chills  Day 11: head ache, space feeling,  blotchy skin  Day 12: severe headache, hives down legs to toes and back of arms with tingling burning sensation.
Miscarriage.  vaccinated December 19th. no Side effects. noticed a bit of pleuritic chest pain. was not bothersome and resolved with ibuprofen.  I was pregnant at the time of first vaccine but did not know. had second vaccine 3 weeks after my first without issue. Went to OBGYn for 10 week appointment and there was no fetal pole. Fetus stopped developing at likely 6-7 weeks. I likely miscarried shortly after my second vaccine. .
Client received 1 dose J&J after having received 2 doses of Moderna. He completed the CDC screening questionaire and denied having had a previous COVID19 vaccine. Form was reviewed by vaccinator and denied previous dose of COVID 19 vaccine.  Upon entering the record into MCIR it was discovered he had previously received 2 doses of Moderna in January.
9x10 cm of redness and  5x5cm of localized swelling. Instructed mom to  apply cold compresses on site of injection
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 72-year-old female patient who received SHINGRIX for prophylaxis. On 5th March 2019, the patient received the 1st dose of SHINGRIX. On 6th March 2019, 1 days after receiving SHINGRIX, the patient experienced injection site pain and muscle pain. On an unknown date, the outcome of the injection site pain and muscle pain were recovering/resolving. It was unknown if the reporter considered the injection site pain and muscle pain to be related to SHINGRIX. Additional details were reported as follows: The reporter was the husband. The patient received SHINGRIX on right arm. The patient experienced pain at the injections site and muscle aches the day after receiving the injection. The reporter consented to follow up. The reporter was in a hurry to get off the phone to call his registered Pharmacist. The reporter was not able to get address and phone number because he was too busy giving details and asking me questions and then had to go.
Conjunctivitis on my left eye.   I called my family doctor but the nurse told me that this is not related on COVID. It might be a coincidence. However the incident happened right after the 2nd covid shot. I'm obligated to report the incident.   The symptom went away in a week without treatment.
c/o rt sided h/a;numbness to rt side of face/head;defines as feeling of novocaine;c/o pain to same area w/light touch;even hair hurts;states neck feels stiff @ base of skull;PERL, hand grasp =;
Swelling and pain at injection site 10 cm in size about 8 hours later. Single hive on face. Significant increase in pain/swelling by the next day - not overly remarkable except sib who got vaccine from the same lot # had same reaction.
Rashes on left side of the body and fever for several days. Now, patient is also irritable.
Patient presents with large area on right upper arm - deltoid area.  The area is indurated, red, hot to the touch.  It is irregular in shape - measures 15 cm by 13 cm at the widest points.  Patient complained of burning and pain from shoulder to elbow.  Patient was referred to her PCP.