chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tested positive for covid; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 31-May-2022 and was forwarded to Moderna on 31-May-2022.    This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (Tested positive for covid) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. and third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Tested positive for covid). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Tested positive for covid) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medications were reported. Reporter stated, 'Both her and her husband have been vaccinated with first and second (Moderna vaccines) and boosted from Pfizer  and both tested positive for covid after. They also took Paxlovid and it helped to recover faster. They are fine now.  Company comment- This is a spontaneous case of interchange of vaccine products (received as a booster dose TOZINAMERAN vaccine) concerning a male patient of unknown age with no medical history reported, who experienced the unexpected AESI COVID-19. Two doses of mRNA-1273 vaccine were administered on unknown dates. Temporal association cannot be assessed due to lack of information on onset date of the event and vaccination dates. It was reported that patient tested positive for COVID after vaccination. He took Paxlovid and it helped to recover faster. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case of interchange of vaccine products (received as a booster dose TOZINAMERAN vaccine) concerning a male patient of unknown age with no medical history reported, who experienced the unexpected AESI COVID-19. Two doses of mRNA-1273 vaccine were administered on unknown dates. Temporal association cannot be assessed due to lack of information on onset date of the event and vaccination dates. It was reported that patient tested positive for COVID after vaccination. He took Paxlovid and it helped to recover faster. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Patient received 2nd dose of Hep A vaccine on 12/22/22, but the nurse administering the vaccine didn't realize it had expired on 12/16/22.  The nurse contacted the manufacturer (GSK), and the rep. gave recs that patient could repeat second dose if serology/ Hep A antibody testing didn't show immunity.  Patient didn't experience adverse reaction to vaccine administration.
chicken pox and/or shingles; chicken pox and/or shingles; Information has been received from a lawyer concerning a case in litigation and refers to a 71-year-old female patient. No information regarding the pt's medical history, concurrent conditions and concomitant medications was reported. On 13-JAN-2011, the pt was administered with zoster vaccine live (ZOSTAVAX) vaccine (dose, route of administration, vaccination site, lot # and expiry date were not specified) at the physician office for the long-term prevention of shingles and zoster-related conditions. As a result pf her receipt of zoster vaccine live (ZOSTAVAX), the pt was caused to suffer chicken pox and/or shingles in or about February 2011, including and all of it sequelae and subsequently was treated by a provider. As a result of her receipt of zoster vaccine live (ZOSTAVAX) , the pt has been caused to suffer severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages. As a direct and proximate result of zoster vaccine live (ZOSTAVAX)'s manufacturing defect, the pt suffered severe and permanent physical injuries, including but not limited to chicken pox and/or shingles, as well as other severe and permanent health consequences. The pt has endured substantial pain and suffering. The pt has incurred significant expenses for medical care and treatment, and will continue to incur such expenses in the future. The pt has lost past earnings and has suffered a loss of earning capacity. The pt  has suffered and would continue to suffer economic loss, and has otherwise been physically, emotionally and economically injured. The pt's injuries and damages ware permanent and would continue into the future. The pt sought actual and punitive damages from the Company as alleged herein. the pt demanded judgment against Company for compensatory, treble, and punitive damages, together with interest, costs of suit, attorneys' fees, and all such other relief as the Court deems proper. The outcome of the events was reported as not recovered. The causality was related.  The events of chicken pox and/or shingles were considered to be disabling.
Noted tongue swollen, bumps both side, tongue white and sides if tongue numb on 4/12/06. Patient reports feeling feverish 4/12/06 and 4/13/06, putting cold water on face to cool off. On 4/15/06 tip of tongue also numb. Seen in ER ON 4/15/06. Given Prednisone (oral) and Pepcid. On 4/16/06 took Benadryl (2) capsules. Tongue felt slightly less swollen after Benadryl, no change in other symptoms. On 4/17/06 tongue feels as it did before Benadryl. All other symptoms continue.
August 21 pt vaccinated at approximately 11 AM, ok until approximately 6 PM. Became very lethargic and ashen gray in color. Right leg red, swollen, hard about 50 cent piece size or a little larger. Temperature 103. Next day, did not awaken. I woke him up about 2 hours to eat. Had a shrill, short cry as if had sore throat or some swelling in throat. Temp continued about 102-103. Following day temp down to 100-101, remained lethargic but was awake for brief periods after feeding, did not play, would smile on occasion. Next day temp was down and by PM had returned to normal. Hematoma continued very hard and tender the size of a walnut right leg only.
Given to individual less than 18 years of age.  Father states child had sore arm from injection but no other complaints.
Information has been received from a health professional concerning a 19 month old male who on 05-AUG-2008 was vaccinated subcutaneously with a dose of MMR II (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3) (lot# 660428/0483X).  There was no concomitant medication.  On 06-AUG-2008 the patient experienced a fever.  The child was seen and given ibuprofen and an unspecified antibiotic (for preventative bacterial infection) on 07-AUG-2008.  The child continued to have fevers of 103-105F for a total of 3 days along with the shakes, 1 episode of diarrhea and blue lips.  The child was taken to the ER on 08-AUG-2008.  ER workup was negative.  Subsequently, the patient recovered on 11-AUG-2008 from a fever, the shakes, diarrhea and blue lips.  Additional information has been received from a nurse indicating that the patient received his first dose of MMR II (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3) (rHA), SQ in the left leg on 05-AUG-2008.  On 05-AUG-2008, the patient experienced very high fever (104-105 degrees F) for 3-4 days with rigors and questionable febrile seizure.  No convulsions or going limp yet bluish color to lips is reported.  The patient went to the ER and had negative septic work-up.  It was reported that the patient recovered.  Very high fever, rigors, questionable febrile seizure and bluish color to lips were considered to be other important medical events.  Additional information has been requested.
Information has been received from a physician concerning an 8 year old female who was vaccinated with VARIVAX (Oka/Merck). The patient reported that the "patient was diagnosed with breakthrough chicken pox after receiving VARIVAX when she was one year old". It was not reported if the patient sought medical attention or not  this is one of several reports from the same source. No further information is available.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Mar2021 at 14:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 01Apr2021 at 13:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 06Sep2021 at 14:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 36 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 28Apr2022 at 09:00 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Immunoglobulin A defficiency" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient did not receive any other medication in 2weeks. The patient recovered and tested negative with minor ongoing symptoms. After several days, on day 9 of start of symptoms, symptoms returned, and she began testing positive again. She was on day 18 of isolation. Doctor was unsure of rebound and considered it a severe case base on symptoms of continuing. She was asked to isolate for 21 days instead of the original 5/10.The patient received treatment Paxlovid from 11May2022 to 16May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
I did not have an adverse reaction to the vaccine. I was out of town and tested positive for COVID-19 on 05/02/2023. I went to the urgent care center close to the hotel. I took over the counter medication to help with my symptoms. As of today, I still have congestion.
the patient stated that he noticed that the left side of his face and his left arm up to the point of injection became numb at about 8:00 pm the evening that he received his second dose of the moderna covid vaccine. He stated that the condition has been improving some as he moves his arm around. I urged the patient to call their primary care doctor to rule out any other possible causes of this issue.
This spontaneous report as received from a health professional refers to a patient of unknown age and gender. On 01-OCT-2014 the patient was vaccinated with an expired RECOMBIVAX HB (expiration date: 07-SEP-2014, lot#, dose, units, route of administration, anatomical location were not reported). The reporter stated the RECOMBIVAX HB did not have any previous temperature excursions. RECOMBIVAX HB was supported with post-expiry data. No adverse symptoms reported. Additional information has been requested.
About 1 week after the injection, I started to have a dull pain in my liver area in the lower right quadrant in the rib cage. It lasted on and off for about 3 month. It felt as if someone was pushing their finger into my lower right rib cage. The sensation would come and go. My shoulder was very tender for 3 days.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 01Sep2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2023, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19, which included treatment with Paxlovid from 17May2023 to 21May2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Woke up in the evening with severe headache, but felt better after hydration and meal.; Felt body aches; flu like symptoms; sleeping all day; This is a spontaneous report received from contactable reporter (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 26Jul2021 18:00 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ZOLOFT. Vaccination history included: Covid-19 vaccine (1st dose, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: HEADACHE (non-serious) with onset 27Jul2021, outcome "recovered" (29Jul2021), described as "Woke up in the evening with severe headache, but felt better after hydration and meal."; PAIN (non-serious) with onset 27Jul2021, outcome "recovered" (27Jul2021), described as "Felt body aches"; INFLUENZA LIKE ILLNESS (non-serious) with onset 27Jul2021, outcome "recovered" (27Jul2021), described as "flu like symptoms"; SOMNOLENCE (non-serious) with onset 27Jul2021, outcome "recovered" (27Jul2021), described as "sleeping all day".  Additional information: On 28Jul2021 resumed to his normal activities with a mild headache. Today 29Jul2021 presented with no symptoms of adverse events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Cellulitis like reaction which began the evening of the PNEUMOVAX administration progressing to moderate pain and swelling of the lower half of the posterior area prompting an ER visit 2 days after the vaccine way administered.
Information was received from a pharmacist and refers to a 40-year-old male patient. The patient's concurrent conditions, medical history, and concomitant medications were not reported. On 09-OCT-2017, the patient was vaccinated with the first dose of the immunization series of GARDASIL 9 intramuscular (lot number: N014470 with expiration date: 17-JUN-2017, dose was not provided) as prophylaxis, based on prescription received by the physician. No adverse event was reported.
1/2 hrs p/having shot diarrhea & h/a, fatigue, hot flashes, nausea, stomach bloated;
Information has been received from a pharmacist concerning a 74 year old female who on 09-APR-2007 was mistakenly vaccinated with varicella virus vaccine live (Oka/Merck) in place of zoster vaccine live (Oka/Merck). The pharmacist reports that confusion was made between the zoster vaccine live (Oka/Merck) and varicella virus vaccine live (Oka/Merck) and varicella virus vaccine live (Oka/Merck) was dispensed instead of zoster vaccine live (Oka/Merck). The nurse did not notice the difference and administered the varicella virus vaccine live (Oka/Merck) rather than the zoster vaccine live (Oka/Merck). There were no problems reported. Unspecified medical attention was sought. The product was properly ordered by the physician. There was no product quality complaint. Additional information has been requested.
Says child had the PEDIARIX on Monday and feels like he is having a reaction to it. Says temp fluctuates up and down, getting up to about 102, says he is "sad", clingy, "lethargic". I asked what she meant by lethargic and she said just not active like usual and slower to respond, clingy, etc. Decreased appetite, drinking ok, esp when fever is down.
Pain in upper back; Pain in ribs; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Pain in upper back) and MUSCULOSKELETAL CHEST PAIN (Pain in ribs) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced BACK PAIN (Pain in upper back) and MUSCULOSKELETAL CHEST PAIN (Pain in ribs). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, BACK PAIN (Pain in upper back) and MUSCULOSKELETAL CHEST PAIN (Pain in ribs) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable.  No relevant concomitant medications reported.
cardiac problem; Pneumonia; significant pain, swelling and rashes across her body.; significant pain, swelling and rashes across her body.; significant pain, swelling and rashes across her body.; Information has been received from a lawyer regarding a case in litigation, concerning a female patient of unknown age. The patient's pertinent medical history, concurrent conditions or concomitant medications were not provided. On 18-OCT-2017, the patient was vaccinated with a dose of Zoster Vaccine Live (ZOSTAVAX) (dosage, route, anatomical location, lot # and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Within a week of receiving the vaccination, in October 2017, the patient suffered debilitating injuries including significant pain, swelling and rashes across her body. Within five months of receiving the vaccine, approximately in March 2018, the patient required hospitalization for pneumonia and cardiac problems. According to the reporter, all injuries were caused by Zoster Vaccine Live (ZOSTAVAX). As a result, the patient suffered serious, progressive, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. At the time of the report, the patient's outcome was unknown.  Upon internal review, the event of pneumonia was considered medically significant.
Extensive diarrhea, mild vomiting, intense sweating during the hours with these symptoms, around 2:30am-4am
1st dose in Sep2021, didn't get the second dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date in September 2021).   On an unknown date, the patient received 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: 02-MAY-2022 Reporter's comments: The reporter was the patient friend. The patient did not get second dose of Shingrix and the reporter asked what to do in such case. Additional Supportive Information: Till the time of reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination.
She got her vaccine, had no issues.  She has a rash on the hairline in the center on the back of her head, neck and itchy towards the center of it.  She thought perhaps a bug bit  her and is spreading now around towards her face and has a tremendous itch.   She went to the clinic and they put her on Kenalog cream twice a day and then they said that she should take Claritin for the itching and Benadryl at night if possible.  They told her in the clinic that she has poison ivy/Dermatitis but she feels it may be related to her vaccine.
She  had a lot of reactions to the Moderna injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (She  had a lot of reactions to the Moderna injection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    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 VACCINATION COMPLICATION (She  had a lot of reactions to the Moderna injection). At the time of the report, VACCINATION COMPLICATION (She  had a lot of reactions to the Moderna injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Patient received the Pfizer shot from us on 5/25/21. When we tried to bill his insurance, we found out that he already received the J&J from another location on 3/15/21. We called the patient to confirm and initially he denied it; later he called back saying he found the immunization card from the other pharmacy so he must have gotten the J&J from them after all.
Myalgia, Diarrhea, NauseaVomiting, fatigue Narrative:
Painful swollen lymph node on left clavicle. Treatment has consisted of ice and naproxen. No change in outcome.
Injection site was red; swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Injection site was red) and VACCINATION SITE SWELLING (swollen) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-1939, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Injection site was red) and VACCINATION SITE SWELLING (swollen). At the time of the report, VACCINATION SITE ERYTHEMA (Injection site was red) and VACCINATION SITE SWELLING (swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medications are provided. treatment to the events not reported.