chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a nurse regarding a 4 month old male patient who received a second dose of Prevnar on Oct 5 2005. On Oct 23 2005, the child developed viral meningitis. No allergies or previous drug reactions reported, medical record unremarkable. Indication for Prevnar was immunization. Product was administered on Oct 5 2005. Dose regimen was 0.5 ml 1 time per day intramuscular. Concomitant medication were not reported. On Oct 5 2005, the patient received a second dose of Prevnar. On Oct 23 2005, the patient developed viral meningitis. On an unspecified date in Oct 2005, a spinal fluid culture was performed that showed no growth for 72 hours. On Oct 24 2005, the patient was hospitalized. His white count on admission was noted to be 42,000. The child was treated with Ampicillin and Rocephin. On an unspecified date the reporter noted that the child's white count had dropped. As of Oct 26 2005 the patient recovered. No additional information was available at the time of this report.
Reinfected with COVID after caring for child with an active COVID infection. Below are my symptoms, and the approximate date they started   1/24 Abdominal discomfort, nausea, and fatigue started 1/25 Extreme fatigue, sore throat, chest tightness, fry cough, and worsening headache  1/26 Body aches, ear pain, feels like there's a lump in my throat 1/27 Neck pain/tension, face tingles like the tingling sensation when a cold sore is starting, eyes ache/burn
feel feverish; headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (feel feverish) and HEADACHE (headache) in a patient of an unknown age and gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced PYREXIA (feel feverish) and HEADACHE (headache). At the time of the report, PYREXIA (feel feverish) and HEADACHE (headache) outcome was unknown.            No concomitant medication was reported. No treatment medication was reported.
Chills and shivering, fever of 101.6, muscle pain, joint pains, and headache. Treated with Advil and Motrin and bed rest. Symptoms lasted 48 hours.
Pt reportedly with fever to 108, per parents 6-8 hours after vaccines given. Tylenol given 101 degrees. 911 called: Paramedics checked patient: looked fine: not transported to ER.
I got Immune thrombocytopenia from the Pfizer Covid 19 shoot number 2; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (Unknown). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for COVID-19 Immunization. The following information was reported: IMMUNE THROMBOCYTOPENIA (medically significant), outcome "unknown", described as "I got Immune thrombocytopenia from the Pfizer Covid 19 shoot number 2".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Swollen cheeks and airway immediately after injection as in allergic reaction to food. Stiffness in arm and bone pain. Nausea, lack of appetite,  and bowel discomfort of all kinds  for two weeks after. 3 days after injection I started menstruation even though I am 2 years into menopause.
Patient reports feeling extreme full body pain starting later in the day of vaccination continuing through the following day. Patient laid on the couch for the whole day and since feels fine, but describes pain as "even my toes nails and hair hurt- everywhere". Pt reports feeling fine two days later, and did not feel like this after 1st dose.
Got period 12 days after last cycle. 1 day after vaccine irregular period occurred; Super heavy bleeding; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 22Sep2021 at 19:00 (at the age of 44-year-old), as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, gastritis and and known allergy to some food coloring which gave the patient hives. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), duloxetine (MANUFACTURER UNKNOWN), loratadine (CLARITIN) and omeprazole (MANUFACTURER UNKNOWN); all for unspecified indication from unknown date and unknown if ongoing. The patient previously received morphine (MANUFACTURER UNKNOWN) and pethidine hydrochloride (DEMEROL); both for unspecified indication from unknown date experienced drug allergy. On 24Sep2021 at 12:00, the patient got period 12 days after last cycle (The patient's menstruation had started on 08Sep2021). 1 day after vaccine irregular period occurred, super heavy bleeding. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events irregular menstruation, heavy menstrual bleeding and short menstruation was not resolved at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: approximately 45 minutes after 1st dose given patient began experiencing numbness and tingling on both hands/fingers and face. Tongue also felt heavy and tingly. Patient reported she took 1 dose of benadryl and 1 tylenol to help with symptoms. she did not have to repeat another dose and felt better later.
Information has been received from a physician concerning a 92 year old female who "a year and a half ago" in approximately May 2007, was vaccinated with ZOSTER (Oka/Merck).  On 11-NOV-2008 the patient experienced shingles.  The patient had sought medical attention from the physician.  At the time of reporting, the outcome of the shingles was unknown.  No further information is available.
The evening of vaccination, noticed extra pain on arm more so than previous dose. Redness showed up right away and spreading the following day. Saw NP for advise Wednesday and iced area. Drew circle around the area and continued to spread. Area also hot to the touch. Inflamed lymph node noticed 1/29 in AM. Virtually saw MD 1/29/21 and prescribed antibiotics and Benadryl 50 mg BID.
got both shots and has been a month with shingles/ both shots last year; shingles, got so bad to; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. In July 2021, between 1 and 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional case details were reported as follows: The reporter was patient's wife. The age at vaccination was not reported. The patient got both shots last year in summer and has been a month with the shingles and got so bad to. The reporter feels bad for him. This case was considered as suspected vaccination failure, as details regarding laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.
My second dose of the Covid vaccine was in April 2021. In September that year, I got shingles which I've never had. I was sick for three weeks. I didn't associate it with the vaccine. But then I also contracted coxsackie virus and pneumonia within the next three months. In December I had my third dose and was fine so I proceeded with my fourth dose on 06/06/20222. I went in that Monday to receive the vaccine and by Tuesday, the next day I had broken out with shingles again. I've spoken with my doctor and I have an upcoming appointment. Although I'm not feeling too badly, the rash is almost identical to the one I had when I had shingles in September of 2021 and I'm having other similar symptoms such as congestion, headache and slight stomach pain. I had my shingles vaccine in April of 2022 which, I believe helped lessen the severity of this outbreak.
Patient was given their 2nd dose of Pfizer COVID-19 vaccine at 16 days after their 1st dose. No adverse effects noted.
Vaccine was administered to patient and immediately after removing the needle from the patient the patient hunched over and passed out.  Patient's father was also in the room with her and held his daughter around her arms while she was sitting and she woke up seconds later.  Then asked the father if he wanted me to call 911 and he declined.
The evening after the shot (about 27 hours later), I had moderate flu-like symptoms, tired, achiness, nausea, headache. These lessened somewhat the next day, but were still noticeable for about 48 hrs.  One week after the shot  and continuing for several days, I noticed that the injection site was warm to the touch and slightly itchy.
cranky, screaming as if in pain, limp sleep; rash, screams cries, unable to nurse comfortably; sleepy, hands twitching diarrhea, spitting up sour; screaming, feels cold, face twitches, fretful eating, spitting up, sz, pale, cold & clammy;
Fever to 105, persistent crying x 24 hrs; APAP & advil given;
Information was received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. During 2014, the patient was inoculated at a pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain condition of herpes zoster. During 2016, the patient was treated at physician office, for a blistering vesicular outbreak and decreased immune symptoms which was then diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
On 10-3-11 Client received Hep B on (R) arm and TDAP on left arm. States no redness or swelling to (R) arm. States (L) arm swelling, redness, itching, and had dizziness, and heart would race at time that same day. States on 2nd day had fever on & off, emesis, stomache, headache, and generalized body aches. Symptoms lasted x 2 wks. as per female client. Cont back page. States on same day called PMD - who informed her it was normal to have some reaction, and to go to E. R. if she has chest pain or feels like she is going to pass out. Also, common law husband called clinic and advised to go to PMD or E.R. that same day. Client did not call. States went to PMD on 10th day - was told by PMD to apply ice, heating pad, take BENADRYL, and take ibuprofen or TYLENOL - nothing also could be done. States after 2 wks - symptoms subsided, and is able to left left arm.
received only the adjuvant part; received only the adjuvant part; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a adult female patient who received Herpes zoster (Shingrix) (batch number KZ455, expiry date 4th February 2023) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 18-APR-2022 Reporter's Comments: Medical assistant reported that, the patient received only the adjuvant part of a shingrix vaccine. The reporter did not consent to follow-up. Additional Supportive Information: The patient received only the adjuvant part of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Information has been received from a registered nurse concerning her son, a currently four year old child, who at approximately 14 months of age, in approximately the year 2000, was vaccinated with a dose of MMR II (lot not reported). Concomitant therapy included vaccination at approximately 14 months of age with a second dose of HIB conj-hep B vaccine (Comvax lot not reported). Subsequently the child developed a high fever, was terribly sick and extremely dehydrated. The child was admitted to the hospital and was on IV therapy for several days and then the child was released from the hospital. The reporter stated her son was in "extensive therapy for speech and gross and fine motor skills." The reporter stated that the child "is still developmental delayed in some aspects, but has improved." Upon internal review, developmental delayed was determined to be an other important medical event (OMIC). Additional info has been requested.
Swollen, itchy area 1"x2" on day 5 and 2"x3" with pustules on day 8 at site of injection
Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) for an unknown indication and COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (COVID-19 VACCINE JANSSEN) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form, ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose and dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (COVID-19 VACCINE JANSSEN) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Fatigue). At the time of the report, FATIGUE (Fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Relevant concomitant medications were not reported.  Patient received COVID-19 Vaccine manufactured by Moderna. Patient received COVID-19 Vaccine manufactured by Johnson and Johnson.  On an unknown date, the patient experienced fatigue for a day and it was resolved.  Treatment information was not provided.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Patient presented early this morning with increasing shortness of breath, chest tightness and associated chills. Treated with laboratory studies, xray and CT for PE studies, EKG x2, BIPAP, decline in status, intubated, CPR , expired.
For a couple of weeks prior to event, I was short of breath and occasionally light headed.  That day I had a very difficult time breathing, pressure in my chest, and too dizzy to walk.  Ambulance took me to emergency room where a scan showed a six inch blood clot across the saddle of my lungs.  A specialist was able to go into my lungs through my groin and suck out the clot.  Three doctors told me I was lucky to be alive.
Moderna COVID-19 Vaccine EUA  Rash on left arm, below where shot was given. Not itchy. Noticed it the second morning after the shot (experienced chills and body aches day after, so didn't look at arm until next day).
pt recv vax & devel an inj site rxn characterized by redness, swelling & itching;it is unk if pt has recovered as of the date of this report;this is one of two patients from this site;
pt recv vax & 4hr pt began screaming, became rigid, held head & scratched face;this episode lasted approx 5min;cont to scream & was taken to ER, where was noted to have a rash on cheeks & chin & a rectal temp of 100.2;sl fever & lump
Client reports 3-4 hours after vaccination developed s/sx of lip swelling and hives. Self reported to a quick care center  and was treated with benadryl and was instructed to take daily x4 days, during which time s/sx resolved. Last dose taken on 3/10/2021. Client reports that on 3/13/21 s/sx returned with swelling of lips. Reported to the ER on that day and was again treated with benadryl. Denied any problems with breathing so declined epi. On 3/14 s/sx included itchy scalp and neck and back pain. Reports to have seen PCP on 3/16 and was prescribed singular daily and an antihistamine (not benadryl).  Symptoms have since resolved.
Information has been received from a physician concerning a cluster of six of seven patients who did not develop sufficient titer after vaccinations with RECOMBIVAX HB. On 23-NOV-2010, 5 patients were vaccinated with a dose of RECOMBIVAX HB (lot number: 666029/1456Y), thimerosal free (dose and site of administration not reported) and 2 patients were vaccinated with a dose of RECOMBIVAX HB (lot number: 666806/0732Z), thimerosal free (dose and site of administration not reported). On 22-DEC-2010, all 7 patients were vaccinated with a dose of RECOMBIVAX HB (lot number: 666805/0657Z), thimerosal free (dose and site of administration not reported). On 25-MAY-2011, 6 patients were vaccinated with a dose of RECOMBIVAX HB (lot number: 669597/0294AA), thimerosal free (dose and site of administration not reported). On 25-MAY-2011, 1 patient was vaccinated with a dose of RECOMBIVAX HB (lot number: 666809/1631Z), thimerosal free (dose and site of administration not reported). Titers drawn in June 2011 showed that six of seven total patients did not developed sufficient titers. The titers were repeated in July 2011 at a second laboratory. The patients did not seek medical attention. At the time of the report, the patients' outcomes were unknown. All telephone attempts to obtain follow-up information have been unsuccessful. Follow up information has been received from the physician who stated that she did not have time to fill out any of the correspondence that she received, but that she had a spreadsheet with all the patient identifiers that she would fax in. Follow up information was received from the physician who reported that his office did not treat any pediatric patients, the office only treated adults. The physician reported that the office purchased the pediatric vials (0.5 ml vial dose) "which are cheaper" and dispensed two vials to each patient to provide an adult dose. Related WAES#s include: 1107USA03575, 1108USA01425, 1108USA01426, 1108USA01427, 1108USA01428. This is one of several reports received from the same source. A standard lot check investigation has been finalized. All in-process quality checks for the lot numbers 669597/0294AA, 666805/0657Z and 666029/1456Y in question were satisfactory. In addition, an expanded lots check investigation were performed. The testing performed on the batches prior to release met all release specifications. The lots met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Patient stated had fever/chills day after vaccine. The 2nd day patient had rash start and it is from neck to groin - none on the legs.
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 14-APR-2011, the patient was administered with a dose of VARIVAX (Lot # 1004Z expiry date unknown) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of 121 reports received from the same source. Additional information has been requested.
Heavy legs  approximately 3 hrs after vaccine taken ,heart beating fast.  The  heavy legs went away after few days but for the next several  weeks heavy legs came back &  continues more frequently up to now.  I went to see my doctor, on May 10, 2021,.,
This spontaneous report as received from a pharmacist refers to a patient of unkonwn age and gender. Pertinent medical history, drug reactions or allergies were not reported. On 23-JAN-2015 the patient was inadvertently administered, with a single dose of ZOSTAVAX, subcutaneous, that was improperly stored (dose, dose number, anatomical location, lot number and expiration date were unspecified). No adverse effects reported. No concomitant therapies were reported. The outcome of the event was unknown. Additional information is not expected because the reporter refused additional contact.
Tasted vaccine within minutes of dose.  Within 15 minutes had itching of face and forearms which lasted about 8 hours.  For 2 nights, but especially the first night, had vivid dreams and woke up every 2 hours.  Had some minor fatigue day after shot.  All resolved by themselves.  Was totally back to normal after 2nd nights sleep.
Ten days post MMR vax pt started with a fever of 101, sore throat and generalized red rash with itching.
Had a Non-severe Allergic Reaction to the first vaccine (Pfizer, lot:EN6205), in March. Delayed 2nd shot, because we were unsure of what outcome could be (no data was present, about reactions to 2nd shots yet)...  Before receiving the 2nd shot I took one Benedryl Tablet.. About an 1 to an hour and a half later, after the shot, I started to get an itching/burning sensation, went home took another Benedryl and proceeded to sleep through the rest of the day. The next day I ended up with body aches and a sore throat and coughing.. the day after that added a mild grade fever and fatigue.
Arm was sore within an hour after the injection & is still sore today (the 23rd).  I woke up on the 22nd with total body aches comparable to the flu & those have lasted even until now (10:00am on the 23rd).  I had a fever (100-degrees) beginning late afternoon on the 22nd & it finally broke early in the morning of the 23rd.  I also have a slight headache that came on early this morning.
Larger red area at site of injection; it divided into two smaller areas. looks like two welts with a bump that looks like a mosquito bite