chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Outbreak of Shingles; Weakness; Chills; Fever; headache; This case was reported by a physician via call center representative and described the occurrence of shingles in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had Shingles approximately 5 years ago.).   In December 2021, the patient received the 1st dose of Shingrix. In December 2021, less than a day after receiving Shingrix, the patient experienced chills, fever and headache. On an unknown date, the patient experienced shingles and weakness. On an unknown date, the outcome of the shingles, chills, fever and weakness were recovered/resolved and the outcome of the headache was unknown.   It was unknown if the reporter considered the shingles, chills, fever, headache and weakness to be related to Shingrix.     Additional Information: GSK Receipt Date: 25-JUL-2022 Reporter's Comment: The case was reported by the husband for her wife. Patient had three outbreaks of shingles before the shot. Then the outbreak was in close proximity to the shot. The reporter stated that the patient received Shingrix vaccine. Patient experienced chills, fever and weakness initially for four days and then had outbreak of shingles. Within 24 hours she developed fever, chills and a headache. Then five days later she had a visible outbreak of shingles. The lot and expiration date of Shingrix vaccine was unavailable. No additional details available at time of medical information communication. The reporter consented to follow up.
Fever, headache, myalgia, lethargic. Locally at injection site->swelling, redness, muscle pain.
red circle  at injection site; red circle which is painful/sore; red circle which is painful and swollen; light headache on and off; chills/shivering; small amount of muscle pain; a little tired; maybe she had a small fever; rash on upper body /shingles; Rash; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received the first dose about 2.5 months prior to the second dose refer case US2020AMR032007).   On 18th February 2020, the patient received the 2nd dose of Shingrix (intramuscular). In February 2020, less than a week after receiving Shingrix, the patient experienced injection site erythema, injection site pain, injection site swelling, headache, chills, myalgia, fatigue, fever, shingles and rash. On an unknown date, the outcome of the injection site erythema, injection site pain, injection site swelling, shingles and rash were recovering/resolving and the outcome of the headache, chills, myalgia, fatigue and fever were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site pain, injection site swelling, headache, chills, myalgia, fatigue and fever to be related to Shingrix. The reporter considered the shingles and rash to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix and had side effects at the injection site (local side effects),red circle which was painful/sore and swollen which was not resolved.  The patient had expected systemic side effects chills, light headache on and off, small amount of muscle pain, a little tired, shivering, and she was not sure if she had a fever because she did not had a thermometer but she says maybe she had a small fever. These systemic side effects had resolved. The patient experienced a rash which she thinks may be shingles. She says the rash was basically on her entire upper body. It was on both sides of her face an on her forehead, it was on both arms as well as her chest, back, and stomach. (No rash on her legs or lower body). It had not resolved.  The reporter feeled that this rash was due to the Shingrix.  The follow up consent was granted.
Motion sickness, mild. Slight headache, slight nausea, increased mucus production while in moving vehicle. Overall tiredness. Treatment : increased fluid intake, staying home.
No additional AE details or PQC; a patient was inadvertently administered a GARDASIL 9 that experienced a supported temp excursion; This spontaneous report was received from an office manager/healthcare business professional (HBP) referring to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies, or concomitant therapies was provided.   On 08-JUL-2022, the patient was inadvertently vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # 1775808, expiration date: 20-AUG-2023, strength, dose, and route of administration were unknown) for prophylaxis. The vaccine had a supported temperature excursion (Incorrect product storage). The vaccine involved was stored at 0.17 Celsius (C) for 192 hours. There was no previous temperature excursion reported. No additional adverse event (AE) details was reported.
This spontaneous report was received from a health care professional refers to a patient of unknown age and gender. On 05-MAY-2015 the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX injection (lot # K018961; expiry: 15-OCT-2016) (dose, route and frequency unspecified). No concomitant medications were reported. No adverse effects reported. There was no product quality complaint involved. The outcome of incorrect product storage was unknown. No further information provided. This is one of several reports received from the same source. Additional information has been requested.
Patient reported soreness in arm 1 day following administration. Soreness at injection site continued to get worse and patient began to run a fever. Patient reported to the hospital and was diagnosed with a blood infection.
Received Pfizer vaccine for second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Received Pfizer vaccine for second dose) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048BZ1A) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No medical history was provided by the reporter.  Concomitant products included DULAGLUTIDE (TRULICITY), GLIPIZIDE and METFORMIN for an unknown indication.   On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-May-2021, the patient started TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage form. On 19-May-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (Received Pfizer vaccine for second dose). On 19-May-2021, PRODUCT ADMINISTRATION ERROR (Received Pfizer vaccine for second dose) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.
GETTING SHINGLES EVER SINCE; This spontaneous report received from a consumer via a company representative via social media concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced getting shingles ever since. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from getting shingles ever since. This report was non-serious.
It began as a sore throat. By the evening of 4/21, there was a burning in the chest, congestion, coughing, sneezing. By the morning of 4/22, fever up to 101.6, and chills ensued through the day and into the next day. Throughout, and still today, there is stiffness and pain in the shoulder of the injection site. I had no such reactions to the previous three Pfizer vaccinations.
In 2015, I started having gastrointestinal issues, diagnosed as GERD, out of nowhere. Symptoms included intense burning in the stomach, diarrhea, and rapid weight loss and fatigue. For the next five years, I continued to worsen, symptoms got worse to include nausea with every meal. I had a food sensitivity panel done in 2016 which showed polyreactivity to foods. In 2019, I was diagnosed with autoimmune disease. I have labs and genetic testing to show this. I currently am polyreactive to almost all foods, critically low vitamin levels resulting in malnutrition, dysbiosis, extreme fatigue.
Swelling and redness on (R) thigh measuring 2.5in x 2.5in. advised cold compress and ibuprofen.
p/vax pt passed out & had a sz; to hosp ER they did blood work & MRI which were all nl;
immediate paresthesias and pain in bilateral arms, Raynaud's ~ 2 weeks later
Patient vaccinated x3 (Pfizer): 1/23/21, 2/13/21, 8/28/21  Patient admitted to hospital on 1/25/22 after testing positive for COVID19
Information has been received on 02-JUL-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 05-OCT-2009, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 01-SEP-2015, the patient was treated at an urgent care and family practice for a blistering vesicular outbreak, which was then diagnosed as or shingles. The patient has been prescribed lidocaine (LIDODERM) patches for management of her painful symptoms. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, 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.
5JUL92 started w/swollen lymph nodes; 7JUL92 started w/rash, low grade fever on face;
This case was reported by a healthcare professional and described the occurrence of injection site redness in a 47-year-old male subject who was vaccinated with HAVRIX 1440 (GlaxoSmithKline), ADACEL.  Concurrent medical conditions included motion sickness.  Previous and/or concurrent vaccination included TYPHIM VI vaccine given on 7 January 2008.  On 7 January 2008 at 17:00 the subject received 1st dose of HAVRIX 1440 (unknown, right arm), On 7 January 2008 the subject received unspecified dose of ADACEL (unknown, anterior portion of right arm).  On 7 January 2008, 29 days after vaccination with HAVRIX 1440 and ADACEL, the subject experienced injection site redness with a dime sized area of irritation around it.  On 31 March 2008, it was quarter sized with redness and itching.  At the time of reporting the outcome of the events were unspecified.  Follow-up information received on 26 June 2008 indicated that the outcome of the vents was unknown.  The reporter felt that the events were related to treatment with HAVRIX.  The onset date of the events was not known, however, the events were reported on 05-February 2008.  Havrix and concurrent TYPHIM VI were administered intramuscularly and the dose of each was 0.5 ml.  Adacel was also given intramuscularly.
9/29/2021 10:23pm shot done 10:33pm pain right side of chest   Tongue numb.  10:43pm arm pain and numbness  11:00pm blurred vision  11:26pm chills   9/30 8:30am woke up. Arm numb. Can?t lift to chest 10:20am entire body tingling   Face numb
This spontaneous report was received from an unknown source and refers to a 20 years old female patient. None preexistent allergies, medical history and concurrent conditions were reported. It was reported that on 16-MAR-2015, the patient was vaccinated with the first dose of MMR II (HSA) (lot#K020188, expiration date 22-OCT-2016) (strength, dose and route were not reported) left arm reported as "Lt Del", that was shipped on 04-MAR-2015 and received on 10-MAR-2015. The product was in transit for 6 days, an the temperature was unspecified. None illness at the time of the vaccination was reported. On 04-MAY-2015, the patient was vaccinated with the second dose of MMR II (HSA) (lot#K021950, expiration date not reported) (strength, dosage and route were not reported) left arm reported as "Lt Del". None relevant diagnostic tests and laboratory data were reported. No adverse effects were reported. This is one of several reports from the same reporter. Additional information is not expected because all information required was received.
No adverse reaction patient stayed for 35 min after injection. Patient was given 0.3ML dose instead of 0.2ML.
An expired dose was given to patient on June 18th, 2021 / vaccine had expired on May 24th, 2021.; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 4-year-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number K7TF9, expiry date 24th May 2021) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 18th June 2021, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 18th June 2021, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient had received an expired dose of Pediarix on 18th June 2021 which had already expired on 24th May 2021.  The reporter consented to follow-up via email.
Heart palpitations at random times. Not daily nor regular, but not a one-time event neither. Not sure when I first noticed it, maybe around September. Could also be related to stress because I am a high school teacher and that is when the new semester started.
Expired vaccine was initially refrigerator on 11-May-2022; Patient received the vaccine on 11-May-2022, which had got expired on 03-May-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine on 11-May-2022, which had got expired on 03-May-2022) and PRODUCT STORAGE ERROR (Expired vaccine was initially refrigerator on 11-May-2022) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 083J21A) for COVID-19 vaccination.     No Medical History information was reported.   In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine on 11-May-2022, which had got expired on 03-May-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired vaccine was initially refrigerator on 11-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine on 11-May-2022, which had got expired on 03-May-2022) and PRODUCT STORAGE ERROR (Expired vaccine was initially refrigerator on 11-May-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. The vaccine got expired on 03-May-2022. Expired vaccine was initially refrigerator on 11-May-2022. The vial did not undergo any temperature excursions. Treatment Not provided.
One day after receiving a PNEUMOVAX. The patient a red patch on skin that was about 4 inches away from the injection site. The red patch was 2 inches by about 4 inches. The red area was very warm to the touch. The patient went to the Dr. and was diagnosed w/ a cellulitis and put on KEFLEX.
Hives, swelling, growing redness and hard lump began on 2/22/2021?8 days after shot
Adverse events: itchy/ scratchy throat, ear flushing, malaise, fever, left arm swelling same day as vaccine.  Treated with Benadryl and Motrin.  Followed up with Pediatrician - advised no further flu vaccines- possible allergy to component of vaccine.
Had Hepatitis b vaccine, dose #2 at 9:30 am. By one pm, arm began hurting. With anthralgia in elbow. Went to ER and primary healthcare provider. Nurse feel that the shot may have hit a nerve when it was being given.
This case was reported in a literature article and described the occurrence of meningococcal infection in a subject who received Meningococcal B Recom vaccine + AlOH + OMV for prophylaxis. On an unknown date, 6 days after receiving Meningococcal B Recom vaccine + AlOH + OMV, the subject developed meningococcal infection. Serious criteria included GSK medically significant. The outcome of meningococcal infection was unknown. The investigator considered that there was a reasonable possibility that the meningococcal infection may have been caused by Meningococcal B Recom vaccine + AlOH + OMV. Additional information was provided. This case was reported in a literature article and described the occurrence of meningococcal B infection in a patient of unspecified age and gender who was vaccinated with unspecified meningococcal B (MenB) vaccine (manufacturer unknown) for prophylaxis. The patient corresponds to table 2 of this literature article. The patient was a part of the study that summarized the university-based outbreaks of meningococcal disease caused by serogroup B in the years following MenB vaccine availability (2013-2018) and described the resulting MenB vaccination responses. The patient belonged to university outbreak during January to May 2015. No information on patient's family or medical history or concurrent condition or concomitant medication was provided. On an unspecified date, the patient received 1 dose of unspecified MenB vaccine (administration route and site unspecified; batch number not provided). Age of vaccination was not provided. On an unspecified date, 6 days after vaccination, the patient developed meningococcal B disease. Treatment was unknown. The outcome of the event was not reported. The author did not comment on the relationship between the event of meningococcal B disease and unspecified meningococcal B vaccine. The author stated, "Achieving high MenB vaccination coverage is necessary to help protect persons during outbreaks of meningococcal disease caused by serogroup B. Efforts are under way to better understand MenB vaccine effectiveness and duration of protection, MenB vaccine strain coverage, and current risk factors for meningococcal disease among university students. This information, along with lessons learned when implementing MenB vaccination campaigns, could help guide and improve responses to future outbreaks." This is 1 of the 2 valid cases reported in the same literature article.
Information has been received from a healthcare professional (who is also the patient) who on an unspecified date was vaccinated (route and site not reported) with the 2nd dose of Gardasil (lot# not reported). On 04-DEC-2007, after receiving the 2nd dose of Gardasil, the patient experienced inflamed lymph node, a pain all throughout her left arm which was the injection site and across her chest. No diagnostic laboratory test were performed. Per the patient, the "swelling has improved and so has the pain". At the time of this report the patient was recovering. Additional information has been requested. 04/07/2008 Initial and follow-up information has been received from a medical assistant (who is also the patient) with allergies to azithromycin and benzoyl peroxide, who on 03-DEC-2007 was vaccinated in the left arm with the 2nd dose of GARDASIL (lot# 658538/1061U). There were no illnesses at the time of the vaccination. On 05-DEC-2007 (previously reported as 04-DEC-2007), the patient experienced inflammed lymph nodes, a pain all throughout her left arm which was the injection site and across her chest. It was reported that no palpable axillary lymph nodes were on the physical examination. However, the patient reported that there was increased pain with palpation of left axilla. There was no adenopathy at other sites. No diagnostic laboratory test were performed. Per the patient, the "swelling has improved and so has the pain". At the time of this report the patient was recovering. On 22-DEC-2007 that patient was vaccinated in the right arm with a third dose of hepatitis B virus vaccine (unspecified). Additional information has been requested.
swelling, warmth and tenderness to the face; swelling, warmth and tenderness to the face; swelling, warmth and tenderness to the face; This is a spontaneous report received by Pfizer from Regulatory Agency (Reference number: GL-O42121-10054) via a contactable Physician reported for a patient. A 58-years-old female patient received an unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unspecified date (age at vaccination was unknown) as dose number unknown, single for COVID-19 immunization. The co-suspect medication included hyaluronic acid (RESTYLANE) via an unspecified route of administration in Feb2020, at unspecified dose for an unspecified indication. The patient's medical history and concomitant medications were not reported. The patient received COVID vaccine approximately 3 weeks ago and on an unspecified date, the patient experienced swelling, warmth and tenderness to the face where Defyne was injected. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient given Pfizer child dose lot #FK5618 on 2/8/2022 at 14:00 by mistake when adult dose was due. Director contacted who advised to bring patient back in for correct adult dose. Patient returned on 2/8/2022 at 14:45 and given Pfizer 33130BA 0.3mL. Provider also notified.
Breakthrough case admission after 2  vaccines Pfizer 7/31/21 Lot# FA7484;  Pfizer 8/21/21 Lot# FC 3180
Started abnormal heart rhythm.   400-500 skipped beats per day.   Mostly PVC.    Not continuous but periodic over the course of the day .   Symptoms have lasted 3 weeks.    PET scan revealed no ischemia at this time .
Vaccine 9/3/02. 9/13/02 Developed Hoenich-Schoenlein purpura--lasted 10 days. 2 hours to MMR.