chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Left eye/cheek/ear/jaw/forehead pain began evening of May 5th; progressively worsened and became more frequent; May 19 started 7-day course of antibiotics prescribed by dentist to rule out sinus infection; at that point, pain behind left eye was 24hrs/day, 7 days a week; saw ENT May 26 who ruled out sinus infection and ordered CT scan of head and prescribed 5 day course of prednisone (seemed to have little/no effect on left eye pain); before CT scan could be scheduled, noticed left pupil significantly contracted; saw ophthalmologist urgently June 3rd, who instructed me to go immediately to ER for suspected Horner Syndrome; admitted to hospital and underwent several CT and MRI scans to rule out tumor/carotid artery dissection/etc. for cause of pressure on trigeminal nerve--none were found; all parasitic lab tests returned negative; during hospital stay continued to have  pain in left eye and left side of face, migraines, and left scalp and chest sensitive to touch, migraines; migraine medication would ease migraine pain, but had no effect on pain and symptoms on left side of face and head; ultimate diagnosis: neurologist and other attending physicians unsure, with best guess partial Horner Syndrome/Raeder Syndrome combined with migraines/cluster headaches, with no apparent cause discernible.
Fever, severe abdominal cramping, extreme nausea, vomiting over 16 hours, pyelonephritis
A non-serious spontaneous report of administration of expired product was received from a registered nurse concerning a five-year-old male who received FLUMIST. The patient is one of 16 pediatric patients who was administered expired product with six patients receiving the vaccine on 31-Dec-2008, three on 02-Jan-2009, six on 05-Jan-2009 and one on 06-Jan-2009. Neither the patient's medical history nor concomitant medications were reported. The patient is one of a pair of siblings who received the FLUMIST on 31-Dec-2008, which expired on 30-Dec-2008. All the expired FLUMIST vaccines were part of the 300 units with same lot# delivered to the pediatric clinic on 21-Oct-2008. All the vaccines were kept in one refrigeration equipment in the clinic and only immunization nurses who work on rotation give the vaccines. The clinic did an inventory of the FLUMIST vaccines on 06-Jan-2009 and it was discovered on that day that expired FLUMIST were given to the 16 patients. There was no adverse event associated with this medication error as of 15-Jan-2009; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Additional information received on 15-Jan-2009 and incorporated into the narrative: patient's demographics and outcome of adverse events.
Soreness in hips (muscles/joints) starting on the right side and then moving to the left side.
Person received Shingrix vaccine and Covid-19 vaccine on 6-16-22. The next days she had an "egg sized" lump on the arm the Shingrix vaccine was given in, had a fever greater than 100 degrees, had body aches and flu -like symptoms for 12 hours.  She states that she was in bed and reached for a glass of water beside the bed and fell in floor because she had no muscle function. Her husband had to call 911 for assistance in getter her back in bed. Her muscles have regained functions but she is very tired, has headache, and still feels like she has the flu.
I had no adverse reactions the first three days after receiving the Pfizer COVID-19 vaccination (first dose), except for a sore arm. On day four at 3pm in the afternoon I broke out in a rash in between and under my breasts, which I treated with Clobetasol cream, and the rash got better.   At 3 am in the morning I broke out in severe hives (welts) on both sides of my abdomen (more pronounced on my left side), under my abdomen and in my groin area. Those areas were very red, raised, itchy and warm to touch.  I did not experience any shortness of breath, swelling of face or throat, or fast heart rate.  There were no changes in my diet, medications, laundry detergent, or bath soap.  I took Benadryl (25 mg) at 3 am and again at 4 am because there was not much improvement.  At 9 am that morning the hives were still present but less red and raised, and not itchy.  I took another Benadryl (25 mg) in the afternoon because the hives had not completely vanished.
Tongue swelled up as big as my mouth and I was having a hard time breathing.  Also had my lip swell and also my throat was swelling up.
Pt explained she had aching in arm near injection site. States pain lasted a few days (approx. 3) and subsided. Claims now the pain has returned and arm is difficult to move.
Case number PHHY2012US051553 is an initial literature report received on 12 Jun 2012. Authors searched VAERS for reports of adverse events (AEs) in pregnant women who received trivalent inactivated influenza vaccine from 01 Jul 1999 through 30 Jun 2009. This case refers to a baby born (sex not specified) to mother (age not specified). The mother was vaccinated with trivalent inactivated influenza vaccine (seasonal influenza vaccine, manufacturer and batch number: unknown) at an unknown gestational age, on an unspecified date between 01 Jul 1999 through 30 Jun 2009 (see linked mother file: PHHY2012US051547). The fetus was exposed to this vaccine via transplacental route. On an unknown date at an unspecified gestational period, the baby was born with birth defect, agenesis of the corpus callosum. The causality was not reported. Authors stated that the VAERS system does not allow for active follow-up of adverse events among pregnant women; thus, pregnancy outcome data are not available for women who had an adverse pregnancy event. Authors concluded that no unusual patterns of pregnancy complications or fetal outcomes were observed in the VAERS reports of pregnant women after the administration of trivalent inactivated influenza vaccine.
Janssen is approved for >18 years old but patient is 16 years old.  No adverse event reported by patient.  Patient was contacted by staff member who spoke Spanish and patient reported he had no side effects.    Date of birth was read incorrectly by vaccinating provider.  Correct DOB was read by person typing into PA-SIIS the next day and patient was contacted right away.
I went to the ER. I was diagnosed with a Bartholin cyst. Then I went to a gynecologist, where they lanced the cyst. It was filled with blood clots. I was given pain medication.
Painful swelling of toes. 3 weeks so far, does not show signs of stopping. Taking naproxen to help. Difficult to walk.
she pulled air into the syringe and injected the air and liquid into the vial/had an issue drawing the vaccine out of the vials/she devised her own way of doing it; This case was reported by a pharmacist via other manufacturer and described the occurrence of wrong technique in product usage process in a patient who received Rabies NVS (RabAvert) (batch number ARBA731A, expiry date September 2023) for prophylaxis.   On 12th August 2020, the patient received RabAvert 1 ml. On an unknown date, unknown after receiving RabAvert, the patient experienced wrong technique in product usage process. On an unknown date, the outcome of the wrong technique in product usage process was unknown.  Additional information was received as follows: Age at vaccination was not applicable for this report. The Pharmacist reported having questions regarding the reconstitution of rabies vaccine. The pharmacist further added of giving the vaccine to a family of 4 last night and that the nurse had an issue drawing the vaccine out of the vials leading to wrong technique in product usage process. She had one of the old products and it went fine, but the 3 new ones were difficult with the withdrawal from the vial.  The first vial the nurse could not get all of the vaccine out and just discarded it as she felt she contaminated it. The next one she devised her own way of doing it, and she pulled air into the syringe and injected the air and liquid into the vial which led to wrong technique in product usage process. The pahrmacist also informed that as per PI, we should never leave a needle in the vial when we reconstitute. The pharmacist further stated that nurses think the vial is different, but the she was not sure because she did not have any of the other lot to compare. Pharmacist did not have any of the patient information while on call. Upon follow up with the pharmacist, pharmacist stated that they have since administered the vaccine and followed the directions and it worked just fine. This case was linked to case US2020AMR163372 and US2020AMR163383 by same reporter. This case was for patient 2 of 3.   On the follow up following internal review it was determined that the initial receipt date (26th August 2020) which is earlier than initially reported.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR163383: US-GLAXOSMITHKLINE-US2020AMR163372:
Myalgia, NauseaVomiting, CHILLS/FEVERISH, PAIN/SWELLING INJ SITE Narrative:
My mom was very ill with fever like symptoms following her first vaccination on January 26th. The symptoms were even worse after her second vaccination March 2nd and included muscle cramping in her legs. Once she was recovered she only had a persistent cough which she attributed to allergies as the pollen count had been high. In the early morning hours of March 19th she was having difficulty breathing and chest pains. She was rushed to the emergency room where she subsequently died of cardio pulmonary embolism which the coroner indicated began within three weeks of her death.
This spontaneous report was received from a pharmacist via a company representative, concerning a female patient of unknown age. Information about the patient's concurrent conditions, medical history or concomitant medication was unknown by reporter. On an unspecified date in December 2018 (reported as within the last week), the patient was vaccinated with PNEUMOVAX 23 for prophylaxis (dose, route of administration, anatomical location, lot number and expiration date were not reported). On an unspecified date in December 2018, the patient went to an unspecified urgent care, because of pain and redness at the injection site and was diagnosed with cellulitis (injection site cellulitis). It was unknown whether or not the patient received any treatment for the cellulitis, if any laboratory diagnostics or studies were performed and if the patient recovered from injection site cellulitis at the reporting time. The causal relationship between PNEUMOVAX 23 and injection site cellulitis was not reported. Upon internal review, injection site cellulitis was determined to be medically significant.
got the shingles weeks after the vaccine/suspected vaccination failure; got the shingles; still in pain; the rash turned my skin black; the rash turned my skin black; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several weeks after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: got the shingles weeks after the vaccine/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: got the shingles), pain (Verbatim: still in pain), rash (Verbatim: the rash turned my skin black) and skin discoloration (Verbatim: the rash turned my skin black). The outcome of the vaccination failure was unknown and the outcome of the shingles, rash and skin discoloration were not reported and the outcome of the pain was not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain, rash and skin discoloration to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, pain, rash and skin discoloration to be related to Shingles vaccine.   Additional Information: GSK receipt date: 31-Mar-2023 The case was received from the patient via interactive digital media. The patient had got the shingles weeks after the vaccine and still in pain and the rash turned his/her skin black. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Dizziness such as vertigo. When rolling over in bed, eyes started "rolling" sensation and the whole room felt like a boat on rough seas. Also nausea and blacking out when got up to go to bathroom. Lasted until 130pm then a migraine started.
Patient seen in July 2022 for SOB that he reports has been present for a year.  Subsequent diagnostic imaging revealed Pleural Effusion and ultimately Mesothelioma.
Varicella given 8/3/15-came in offive 8/6/15. Had redden area 2 1/2 circle with and center circle 1 1/2- which was raised-and slightly- blistering (very small))-No temp no other symptoms.
This spontaneous report was received from a nurse and refers to a 19-year-old patient of unknown gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history. On 27-DEC-2017, the patient was vaccinated with a pediatric dose of VAQTA, 0.5 ml, once, (lot number and expiration date were not reported) instead of an adult dose, for prophylaxis. The reporter denied any adverse effects reported by the patient.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2009, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, the very virus that ZOSTAVAX was intended to prevent. In 2011, the patient was treated at a medical center for a vesicular outbreak that was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX, vaccine, and/or despite receiving 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.
Patient administered vaccine after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture date of expiration) in a 54-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 12-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was reported.  Date the vial was initially stored in the refrigerator was unknown. Expiration date was reported as 07-Apr-2022. The vial did not undergo any temperature excursions.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up received reporter address updated.
When I open the package there was liquid in the package and I saw a crack in the vial; The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 02Nov2023, this case now contains all required information to be considered valid.  This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Pharmacist) from product quality group, Program ID.  A patient (no qualifiers provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unnown, single (Lot number: HF5515, Expiration Date: Feb2025) for immunisation; for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious), outcome "unknown", described as "When I open the package there was liquid in the package and I saw a crack in the vial". Additional information: NDC number of Abrysvo was 0069034405, UPC number of Abrysvo was 300690344058. They were reporting about the incident in the newly opened Abrysvo package that they had so, she mentioned that there was a crack in vial coming out of it. It is not yet administered to any patient. When she open the package there was liquid in the package and she saw a crack in the vial. The syringe of Abrysvo that was broken in the package, it was the last one and it was a cracked antigen vial that you put the adapter on.  Causality for "when i open the package there was liquid in the package and i saw a crack in the vial" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v has been requested and will be submitted if and when received.
Fever, chills, body pain, headache, nausea, loss of appetite, dizzy for 1 week.
COLD SWEATS; CHILLS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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 not reported, batch number: Unk) 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 subject experienced cold sweats, and chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills and cold sweats was not reported. This report was non-serious.
I developed hives between my breasts and on my chest within 10 days after receiving the second dose of the COVID 19 vaccine from Pfizer. It was very itchy and red and uncomfortable. Anytime clothing touched it, it was itchy.
Pt vaccinated with Engerix-B developed soreness of lt arm, chills, sweats, temp 101, pneumonia shown by chest xray in ER; Not known if pneumonia was causative or an effect of immunization.
experienced arm soreness; This case was reported by a consumer via call center representative and described the occurrence of pain in extremity in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in extremity. On an unknown date, the outcome of the pain in extremity was unknown.   It was unknown if the reporter considered the pain in extremity to be related to Shingrix.  Additional details provided were as follows: The case was reported by the patient's sister. Age at vaccination was not reported. The patient received a dose of Shingrix and experienced soreness in arm. The reporter gave limited information. The reporter did not consented to follow-up.
3 to 4 days experienced fatigue; Low grade fever; Experienced ongoing intermittent cramping in legs; Experienced ongoing intermittent cramping in arms; Cramping in all areas of the body; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown), via an unspecified route of administration in Left deltoid on 29Apr2021 at 16:00 as single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications were reported. Prior to vaccination, patient was not diagnosed with COVID-19; Since the vaccination, patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 04May2021 at 03:45, patient experienced fatigue, low grade fever, cramping in legs, arms, and cramping in body. No therapeutic measures were taken as a result of reported events. The adverse event did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of the event fatigue, low grade fever, cramping in legs, arms, and cramping in body were not recovered at the time of report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Initial report was received on 23 August 2012 from a health care professional. A female patient (age and date of birth not reported) with no reported past medical history had received MENACTRA (lot number, route, site and date of administration not reported) and an unspecified amount of time after vaccination, experienced numbness in left limb down to feet. No further information was provided at the time of the report. The patient's outcome was not reported. The reporter for this case is the same as for case 2012-07889 and 2012-07890. Documents held by sender: none.
Reports symptoms started 24 hours after vaccine administration. Left arm with area of erythema, swelling, and warmth at site of injection. Afebrile. Advised ice and Tylenol and return if symptoms worsen.
Pain and swelling in left arm and hand which persisted for 2 days. Patient took over the counter diphenhydramine 25 mg. Pain and swelling resolved on 3rd day with no additional consequences.
After first vaccine on 3/22/2001 developed hives on left arm 140 days after first vaccine on August 11, 2021.  Hives re-occurred every week on different spot - mainly at night.  Always on arms, back, stomach, or neck.  Never in legs or face.  Went to Dermatologist on  who prescribed over the counter.  The hives re-occurred and is chronic.
No additional AE reported; PROQUAD was administered on 2/3/2021 and expired on 1/19/2021; This spontaneous report was received from a patient of unknown age referring to himself/herself. The patient's concomitant medication, pertinent medical history and drug reactions and allergies were not provided.      On 03-FEB-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength and route were not provided; lot# was S022917 and expiration date was 19-JAN-2021) 0.5 ml for prophylaxis (expired product administered). No additional adverse event (AE) was reported (no adverse event). The outcome of the events was unknown.
Immediately after the vaccine, I encountered normal side effects of exhaustion and injection site pain.  All subsided within 72 hours.  On 5/9/2021 approximately 6pm I felt tightness in my left ear and throat area.  As the evening proceeded, I noticed enlarged lyph nodes throughout the neck and throat.  They are continuing as I type this on 5/10/2021.  This did not occur from the first vaccine on 3/31/2021.
pt recv vax & soon p/vax pt devel greater than 50 lesions;
This spontaneous report was received from an unspecified female patient of unknown age. No concurrent condition or medical history was reported. On an unknown date the patient was vaccinated with ZOSTAVAX (dose and route of administration not provided). No concomitant therapy was reported. The patient reported that she felt depressed since vaccination. The outcome of the event was reported as not recovered. The causality assessment was not reported. No product quality issue was involved. Additional information is not expected, no healthcare professional contact details were provided.