chrisvoncsefalvay/vaers-outcomes huggingface dataset:
developed symptoms for Covid/tested positive after receiving the vaccine; developed symptoms for Covid/tested positive after receiving the vaccine; developed symptoms for Covid/tested positive after receiving the vaccine; This is a spontaneous report from a contactable physician (patient) and a consumer (patient's spouse). A 67-year-old male patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number: EH9899; expiration date: not known), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The physician had a question. As a patient, he received the first dose of Pfizer BioNTech vaccine and on an unspecified date, two days later, he developed symptoms for Covid and tested positive after receiving the vaccine. He stated this had nothing to do with vaccine but had to do with the timing. He wanted to know if should take or delay vaccine. He is doing fine now. His second dose is coming up next week. The outcome of the events was recovered on an unspecified date.; Sender's Comments: The association between the event lack of effect (he developed symptoms for COVID and tested positive) with BNT162b2 can not be completely excluded.
Average of two nose bleeds a day starting 4 days after vaccination was received. The heaviness and frequency is unusual for this child. The tissue/cotton balls that were stuffed into the nostrils had long, thick, earthworm like blood clots on them when the tissue was removed from being over saturated. Nosebleeds lasted average 10 minutes each time. 8 days after vaccinated, this child had a nose bleed through both nostrils simultaneously and it was so much blood, the parent (me) spoke to the doctor on call. No further care was recommended other than the usual ice pack, pinch sinuses, use humidifier at night; but I was told to keep an eye for symptoms of low platelets. No nose bleeds yesterday and so far today, as far as I know. He's in school.
child got <mild case of varicella 15 chickenpox p/vax 3yr ago;
(1) Rash appeared at injection site 8 days after vaccination. It was inflamed and mildly itchy, but not painful. (2) Subconjunctival hemorrhage appeared 9 days after vaccination (left eye).
Fever 102 degrees  12 hrs after injection  lasting  8 or so hrs.  34 hrs later dizziness and fainting  lasting a short while.
Shortness of breath started late April and into early May and dramatically worsened 5/6/2021 leading to emergent evaluation and diagnostic testing revealed DVT and multiple PE, hospitalization and surgery and on long term anticoagulation; she is on outpatient anticoagulation now and returned to work
MA gave 17 year old Flublok instead of prescribed Fluzone Quadrivalent. No adverse event; MA gave 17 year old Flublok instead of prescribed Fluzone Quadrivalent. No adverse event; Initial information received on 24-Sep-2019 regarding an unsolicited valid non-serious case received from a Nurse via office Staff.  This case is linked with 2019SA267186, 2019SA267187, 2019SA267188 (same reporter)  This case involves a 17 years old male patient who was vaccinated with dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] instead of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccine included Menactra (MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX))   On 18 Sep 2019, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE Frequency : once, lot QFAA1918, exp date: 30 June 2020 intramuscularly in left arm instead of prescribed dose of INFLUENZA QUADRIVAL A-B VACCINE lot number not reported.  It was a case of actual medication error due to Inappropriate age at vaccine administration and wrong vaccine administered.  At the time of the report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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 the sender: none
on lt leg 1" x 1" marking w/brown skin discoloration can see needle tracks into skin;
stomach pain; goosebumps.on scalp; made my.palm very very itchy.plus my ear and ankle/next day itchy; didn't sleep; sore arm; sore; no energy; This case was reported by a consumer and described the occurrence of stomach pain in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 8 years ago).   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than a day after receiving Shingles vaccine, the patient experienced stomach pain, goose flesh, itchy skin, sleeplessness, pain in arm, pain and energy decreased. On an unknown date, the outcome of the stomach pain, goose flesh, itchy skin, sleeplessness, pain in arm, pain and energy decreased were unknown.   It was unknown if the reporter considered the stomach pain, goose flesh, itchy skin, sleeplessness, pain in arm, pain and energy decreased to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had goosebumps, very itchy in ear and ankle. The patient did not sleep because of stomach pain and sore arm. The patient had itchy, sore and no energy The patient was afraid to take another one in 2 months and should heard take another one.
Pt presented with hives and redness on chin, neck and upper chest, tingling sensation  present in lips and tongue.  BP: 190/110, HR: 82, O2 sat: 95%. Administered 25mg PO liquid Benedryl. Pt released from observation once hives dissipate.
Patient passed out after receiving vaccine, he was responsive and able to speak. Vitals were taken hr-84, b/p-92/62, t-97.5, O2-96 room air. He was assessed by nursing team, no injuries or issues noted. Mom state that he did not have breakfast, he was given water and snacks. He was monitored for 15 minutes, patient was stable on discharge
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe
pt recvd vax;eve of vax,devel blotchy rash on stomach,spread to forearm;seen in med ctr;joints achy & swollen also;CXR & lab work done;on Ibuprofen;probable dx:rxn to hep B vax;
Child is an immigrant. He presented to the clinic with his mother and family friend requesting vaccinations be given so child can start school. Mother did not have a copy of the child's immunization record. It was determined that child would start immunization schedule over and mother was in agreement. Mother denied any previous issues with vaccines and initially reported that the child had not received any immunizations in the past 4 weeks. Child was to be given 7 immunizations. After administering the 4 listed above to the left arm, he fainted while sitting in chair. He was out for approximately 20 seconds. After being stimulated with an ammonia capsule and verbal stimuli, patient awakened and was carried to an exam table where he laid down. He appeared to be very tired for about 5 minutes after fainting and just wanted to rest with his eyes closed. No signs/symptoms of an allergic reaction were found. He would respond to questions appropriately  and open his eyes when requested. Respirations were even and unlabored. His vitals were taken routinely and all were within normal limits. After 5-7 minutes, patient returned to baseline. He sat up, began smiling and laughing. When asked orientation questions he answered all appropriately. A small, fine tremor to bilateral lower extremities was noted, but subsided after patient sat up and began talking . He ate a granola bar and drank 8 oz of water. Child did complain of left arm soreness, but no dizziness or headache. After immunizations were given the mother reported that the child did receive a flu vaccine 2 weeks ago, but was unsure of which kind. She denied patient receiving any other vaccines at that time. The remaining 3 immunizations were not given at this visit. When he left the clinic, he had returned 100% to baseline. His gait was balanced and he was alert and oriented X4, respirations even and unlabored. We advised mother that patient should receive future immunizations at a clinic where a doctor is on sight in case the fainting occurs again. Mother verbalized understanding.
Rash on her arm; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 25Sep2021 at around 09:00, as the first single dose, for COVID-19 immunization. Medical history and concomitant medications were not reported. On 28Sep2021 the patient experienced breaking out in rash on her arm. The patient stated that from time to time, without thinking about it, she pulled weeds when they grew up and she did that a couple of days before, but she washed her arms. She was not sure if she came into contact with poison ivy or if this was one of the side effects. Event outcome was unknown.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Fluzone High Dose vaccine was ordered on 12-Oct-2019 and it did not come off the following day like it should have so it was ordered again on 13-Oct-2019 with no AE; Initial information received on 14-Oct-2019 and follow-up information receive on 15-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves 86-year-old male patient who received 0.5 ml dose of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] prefilled syringe (lot: UJ242AA and expiry: 04-May-2020) via intramuscular route and in left deltoid on 12-Oct-2019 and in left interior deltoid on 13-Oct-2019.  The patient past medical history, medical treatment(s), vaccination(s) and family history were not provided.  No other vaccine was given.  It was an actual medication error due to extra dose administered. It was reported that Fluzone High Dose vaccine was ordered on 12-Oct-2019 and it did not come off the following day like it should have so it was ordered again on 13-Oct-2019 (extra dose administered). The patient has not experienced any adverse effects at this time.  At the time of reporting, the patient had no adverse event.  It was reported that the patient was in the hospital for an infection not related to the Fluzone High dose vaccine.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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.
Pfizer- BioNTech Vaccine: Individual received the vaccine at 11:45 am. At 12:00 pm she c/o of frontal lobe headache and nausea. Vitals at 12 noon 129/79, 66, 97%; 12:05 pm 128/80,69, 97 %, 98.5 temp; 12:10 pm 113/80, 69, 97% SATS, 98.5 Temp. Individual was stable and drive self-home.
Scratchy throat, nausea. BPs 156/105 (pulse 60), 130/90. O2 sat 99%.
I did not have much of a reaction, I don't remember. A month later, I got COVID-19 after a trip. When I got home, I had a COVID-19 home test and it was positive. I had a sore throat, I lost my taste and smell, no fever I also have been problems with my eyes. I had drainage on my eye, but the doctor said it was not an infection., this health issue injured my cornea.
pt recvd vax;lt leg where vax adm,very red & very swollen;had high pitched uncontrollable crying for over 3 hrs per mom;
6/29  57y.o. male with history of alcohol use disorder, cocaine use disorder, CAD, chronic back pain, COPD, HLD, HTN, OSA, DM2, tobacco use, depression present with shortness of breath, cough, dyspnea.
Extensive area of urticarial type erythema, very pruritic c/w allergic reaction.
Extreme fatigue; Nausea; Vomiting; This is a spontaneous report from a non-contactable consumer, the patient. A 33-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on an unknown date in Apr2021 at 08:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Apr2021 at 20:00, the patient experienced extreme fatigue, nausea and vomiting. 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 extreme fatigue, nausea and vomiting was resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
Patient was 13 years and 1 week old at the time of vaccination. Instead of the purple cap/grey cap Pfizer for ages 12+, I (the Pharmacist on duty on 1/28/2022) administered the orange cap Pediatric Pfizer formulation.
Very red, hot area 3 1/2" x 3/12" in size at injection site.
VACCINE WAS ADMINISTERED 13 + HOURS AFTER PUNCTION OF VIAL WHEN MANUFACTURERS RECOMMENDS TO BE ADMINISTERED IN A 12 HOUR PERIOD. AT THE TIME, PATIENT REPORTS NO ADVERSE EVENT.
Not sure if it has anything to do with the shot???  I had surgery on September 13, 2021 and had excessive bleeding, to the point that I was admitted to the hospital for 3 days.  My blood would not clot and slow down.  My hemoglobin dropped to 7.1
Pt received Pfizer dose #1 today at 3:40 pm.  At 4 pm, patient reported feeling very dizzy and didn't feel well. Sweat shirt removed and she was lowered to the floor.  Laying on the floor, vitals were 94/65, HR 69 93% O2.  Pt felt better after laying on the floor, repeat BP 95/65. HR 70.  Up to sitting position on the floor, patient felt ok, BP to 106/72, HR 67 O2 98%.  Pt up to chair sitting comfortably at 1619, BP 102/62. HR 90, O2 96%.  Pt ate granola bar and 2 water bottles.  Ambulated to car in no distress, roommate to drive home.  Advised to drink water and eat meal with protein/ rest tonight.
Information has been received on 26-MAY-2017 regarding a case in litigation from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported.  The patient was inoculated with ZOSTAVAX (lot number and expiration not reported) subcutaneous on or about December of 2006 by a physician, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 25-JAN-2016, the patient was treated by a physician for a vesicular outbreak that was diagnosed as severe shingles. The patient was prescribed valacyclovir hydrochloride (VALTREX) for management of his painful symptoms. 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.
The patient developed a rash approximately six hours after the vaccination. The rash involved mainly her arms and legs and was pinpoint papular in nature. It was very itchy. It became a confluent red patch along both arms and her lower legs that remains itchy today.
pain going down her arm; can't reach to put on the seatbelt; This spontaneous case was reported by a non-health professional and describes the occurrence of PAIN IN EXTREMITY (pain going down her arm) and LIMB DISCOMFORT (can't reach to put on the seatbelt) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 032L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, 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 experienced PAIN IN EXTREMITY (pain going down her arm) and LIMB DISCOMFORT (can't reach to put on the seatbelt). At the time of the report, PAIN IN EXTREMITY (pain going down her arm) and LIMB DISCOMFORT (can't reach to put on the seatbelt) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the events was not applicable. No concomitant medication details was reported. No treatment medication details was reported.
Information has been received from a physician concerning a 65 year old male with lymphoma who was inadvertently vaccinated with a 1.0mL dose of pneumococcal 23v polysaccharide vaccine. Subsequently the pt complained of tenderness and erythema at vaccination site (unspecified), as well as low grade fever. Medical attention was sought. The pt's outcome was unk. Additional information has been requested.
After the first dose, everything was fine. However, after receiving the second dose, one month later, I started suffering from seizures. It started out of nowhere and now I have seizures at least once a month since receiving the second dose. My physician has diagnosed me with epilepsy after doing MRI and CT scans. I've lost three jobs since my diagnosis; my doctor prescribed me KEPPRA for the first six months since diagnosis, but it's been causing major breakouts and isn't stopping the seizures. I was recently prescribed cephalexin 500mg daily and lamotrigine 25mg daily as well folic acid. As of now, I just had a seizure yesterday so nothing is helping currently.
Information has been received from a registered nurse concerning her 5 year old son with no pertinent medical history and no drug reactions/allergies, who on 07-MAR-2003 and 28-JAN-2004 was vaccinated with a first, second and third doses of RECOMBIVAX HB (lot numbers: "1218M", "1100M" and 646602/0751N). Concomitant therapy on 07-APR-2004 included MMR (lot number: 646898/0950N) and VARIVAX (lot number: 646135/0848N); and on 07-MAR-2003 and 07-MAY-2003 and DTP VACCINE ABSORBED USP, INFANRIX-IPV and PNU-IMUNE. After her son's first birthday, he presented with symptoms (unspecified). After his "first vaccinations", (approximately March 2003) he visited the doctor's office due to high fever, diarrhea and vomiting. On 15-MAY-2003 his "face was droopy". In approximately October 2005 the patient was diagnosed with autism. No further information was available. Unspecified medical attention was sought. The outcome was reported as not recovered. There was no product quality complaint. The events were considered to be disabling by the reporter. Additional information has been requested.
No additional adverse events.; multiple doses of VAQTA administered since temperature excursion that occurred 16JUN202; This spontaneous report was received from a consumer and refers to a patient of unknown age and gender. The patient's medical history, concomitant therapies and concurrent conditions were not provided.  On 28-JUN-2022, the patient was vaccinated with 1 dose of improperly stored hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, prefilled syringe, lot # U012678, expiration date 18-JAN-2023 (exact dose, dose number, strength, route of administration and anatomical location were not provided) for prophylaxis (product storage error). The administered hepatitis a vaccine, inactivated (VAQTA) underwent temperature excursion that took place on 16-JUN-2022 with 8.5 Celsius degrees for 10 minutes. Previous temperature excursion took place on an unknown date in May 2022 with 8.8 Celsius degrees for 11 minutes. No additional adverse events were reported (no adverse event).  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2207USA001345: US-009507513-2207USA004688: US-009507513-2207USA004690: US-009507513-2207USA004691: US-009507513-2207USA004695: US-009507513-2207USA004698: US-009507513-2207USA004700: US-009507513-2207USA004707: US-009507513-2207USA004709: US-009507513-2207USA004710: US-009507513-2207USA004712: US-009507513-2207USA004714: US-009507513-2207USA004715:
This spontaneous report as received from a physician via a company representative refers to a 70-year-old female patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 05-APR-2017, the patient was vaccinated with PNEUMOVAX23 lot # N003997 for prevention of pneumonia (dose, route of administration and expiration date were not reported). On the same day, the patient experienced swelling, pain, and a hot feeling at the injection site. The patient was diagnosed with cellulitis. The patient sought medical attention. Unspecified treatment was given for the adverse event. No lab diagnostic tests were performed. The outcome of the event and the relatedness between the event and PNEUMOVAX23 were not reported. Upon internal review, the event of cellulitis was determined to be medically significant. Additional information has been requested.
After vaccination, the provider incurred a needle stick.  The involved patient was no impacted.  Client is handling the situation
1 day after flu shot administered to right thigh, developed redness, progressing with pain, tenderness, warmth consistent with cellulitis.  Treated with Keflex.
Red rash; Hives; Itching; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EW0158) via an unspecified route of administration in the left arm on 22Apr2021 at 21:30 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. Medical history included hypertension, arthritis and obesity. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received unspecified concomitant medications. The patient previously received tetracycline (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN), and cholesterol medicines (MANUFACTURER UNKNOWN); all from unknown dates for unknown indications and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ER8733) via an unspecified route of administration in the left arm on 30Mar2021 at 12:00 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. On 22Apr2021 at 22:15, the patient experienced red rash, hives and itching. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the reported events which included treatment with diphenhydramine hydrochloride (BENADRYL) 50 mg orally. The clinical outcome of the events red rash, hives and itching were recovered on an unspecified date in 2021 at the time of this report.   No follow-up attempts are needed. No further information is expected.