chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PROQUAD that underwent a temperature excursion was admnistered; No additional adverse effects reported; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies, or concomitant medication were not reported.  On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) lot number U015481 with expiration date 13-NOV-2022 (dosage, route of administration and anatomical location were not reported) for prophylaxis, which underwent a temperature excursion, at 14 to 46°F (33F) for 8 hours 0 minutes and 0 seconds (Product storage error). There was no previous temperature excursion. No additional adverse effect reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2110USA002855:
Pt vaccinated with DTP 45 hrs after DPT pt had 3 repetitive eventss ovr 40 min consisting of fussiness followed by limpness. His color during the event was described as very pale.
Severe neck pain on my left side starting from the base of my neck and going down my left arm. Left arm is very weak when using it. Have a hard time turning neck
Developed cellulitis like symptoms, redness, tenderness, swollen & warm to touch on affected area (whole upper arm rt.). Seen by medical director on 7/21/11, was advised to go to ER.
Information has been received from a Physician Assistant (P.A.) concerning a 20 year old female with a history of hives once a year who on 21-FEB-2007 was vaccinated IM with a dose of HPV, lot # 655618/0786U. On 22-FEB-2007 the patient developed hives over her entire body and vomiting. The reporter also noted that in addition to her history of hives, members of her family had a stomach virus with vomiting so it was unclear if her symptoms were from the vaccine. BENADRYL was ordered for the hives. The patient's outcome was unknown. Additional information has been requested.
Small pea sized bump under the skin at the site where the vaccine was given. Right thigh is the leg that has had the reaction.
I informed the woman who gave me the shot that i have MCS - Multiple Chemcial Sensitivities - and I had had two previous anaphalactic reactions - once to shellfish and once to preservatives on lettuce.  After the shot, I was taken to the ER and monitored for 15 minutes.  I didn't have a reaction, so I was excused.  Thirty-forty minutes after that at home, I started to experience flu-like symptoms and extreme pain on the outside of my upper body.  My upper body felt like it was burning and swelling and my chest started cramping - and my throat felt like it was closing.  This lasted for one hour.  Then all those symptoms moved to my lower body and that lasted for one hour.  After that, the symptoms slowly subsided.
About 10 minutes after hep b vaccine given, employee started complaining of feeling head/neck pounding, ringing in the ears, and hot.
There was no adverse reaction. Patient was given incorrect vaccine; instead of Hep B, he was given flu vaccine (details of vaccine; type, brand and lot number was not provided by clinic).
This spontaneous report was received from a healthcare worker refers to a patients of unknown age and gender. No concurrent condition or medical history was reported. The healthcare worker reported that on an unknown date between April 2015 through June 2015, 17 doses of (Oka/Merck) VARIVAX (lot # L001325, dose and route of administration not provided) that was improperly stored had been administered. No adverse effects was reported. The outcome of the event was unknown. No product quality issue was involved. Additional information is not expected, no contact details were provided.
Site: Pain at Injection Site-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild
Tested positive for Covid virus, after being fully vaccinated.; Tested positive for Covid virus, after being fully vaccinated.; This is a spontaneous report from a contactable consumer or other non hcp. A 73-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection) dose 1 via an unspecified route of administration on 26Jan2021 (Lot Number: EN5318) as dose 1, single and with lot number (EL9266), via an unspecified route of administration on 12Feb2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient tested positive for COVID virus, after being fully vaccinated (after two doses) on 10Aug2021. The patient underwent lab tests and procedures which included Covid test (sars-cov-2 test:) positive on 10Aug2021. The outcome of the events was unknown.   Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101075254 Same reporter/drug/AE, different patients
4 days after MMR, she screamed bloody murder all night long. Took her to Dr., found nothing, prescribed Tylenol with Codeine. About 10 days after vaccination, she began to regress in her motor skills by no longer crawling, sitting, and barely able to hold head up or feed herself. She was sent to a Neurologist who found a brain abnormality from the MRI. This abnormality was where the brain controls motor skills. As of now, she is able to hold her head up, but still cannot sit or crawl and remains up most nights.
On 8/17/2021 patient was hospitalized due to acute COVID infection, requiring mechanical ventilation
Arm pain and swelling at injection site. BENADRYL and ibuprofen given. No medical visit yet.
On Friday, July 16,2021, Patient was wrongly administered 0.5ml of Pfizer Vaccine instead of 0.3ml by a Medical Nurse.  Incident was reported to Management, Patients will be notified by medical staff.
This spontaneous report as received from a pharmacy technician refers to a female patient of unknown age. On an unknown dates, the patient was vaccinated with two doses of ZOSTAVAX vaccine within a little over 1 year time (dose, route, lot number were not reported). No adverse effects were reported. The patient's outcome was not reported. Additional information has been requested.
Daughter reports following day case became "body heavy" Reports since then has had paralysis in arms and legs and puritis all over.
Initial case was received from a healthcare provider on 06 November 2012. A 45-year-old female patient received a dose of intramuscular injection of FLUZONE, sanofi pasteur Inc., lot number UH748AB on 26 September 2012. The next morning, on 27 September 2012, the patient woke up feeling "achy". Over the next week, the achiness increased. Then neuropathy started in her feet and generalized weakness in her hands, arms and low back, accompanied by extreme fatigue (onset dates not reported). The patient's medical history and concomitant medications were not reported. The patient had multiple magnetic resonance imaging (MRIs) and spinal tap (results not reported) on unspecified dates. No treatments were reported. On 01 November 2012, the patient was told she had Guillain-Barre. The patient's outcome was not reported. Documents held by sender: None.
Patient had a sore shoulder and was lethargic for a couple of hours; Patient had a sore shoulder and was lethargic for a couple of hours; This spontaneous case was reported by a patient and describes the occurrence of LETHARGY (Patient had a sore shoulder and was lethargic for a couple of hours) and ARTHRALGIA (Patient had a sore shoulder and was lethargic for a couple of hours) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066F21A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (en6201, no expiration date was provided.) on 10-Feb-2021 and Pfizer. Past adverse reactions to the above products included Adverse drug reaction with Pfizer and Pfizer.    On 17-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LETHARGY (Patient had a sore shoulder and was lethargic for a couple of hours) and ARTHRALGIA (Patient had a sore shoulder and was lethargic for a couple of hours). At the time of the report, LETHARGY (Patient had a sore shoulder and was lethargic for a couple of hours) and ARTHRALGIA (Patient had a sore shoulder and was lethargic for a couple of hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication use information was not provided by reporter.  The patient reported side effects to his one Moderna Covid-19 vaccine which was his third Covid-19 vaccine. The other vaccines including his fourth vaccine were all Pfizer vaccines.   The patient received a Pfizer Covid -19 vaccine on the February 10, 2021, no expiration date was provided. Patient did not remember arm. Patient had a sore shoulder but did not have anything beyond that. Patient may had been lethargic for a couple of hours after the vaccine. The patient did drive himself home. The patient had the Pfizer Covid-19 for his first and second doses.   The patient received first Moderna vaccine was November 17, 2021, expiration date was not known. Arm of injection was not known. Patient had a sore shoulder and was lethargic for a couple of hours. The patient thought that he had a Moderna vaccine for his fourth dose however at the end of the telephone interview the patient realized that he had a Pfizer vaccine for his fourth Covid-19 dose.  Treatment medication use information was not provided by reporter.
Swelling and painful/stinging lips.   No immediate reaction, sore arm and a little fluish the next day
Small blister right on the injection site; This is a spontaneous report from contactable consumer (patient). A patient of unspecified age and gender received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, patient stated, I just got the vaccine the other day and I have a symptoms that I haven't seen anywhere, it's a small blister right on the injection site. Have you been hearing anything about those? Is that common. When informed about Pfizer Medical Information department, consumer added, No, I have just wasted a lot of time. Can you just tell me if it was common or not. was there anything I should worry about. When again informed about  Medical Information Department, consumer stated, but you said you were Pharmacist, that was enough for me. Consumer hung up the call abruptly, hence, product details (LOT#, expiration date, NDC# and UPC#) and other details were unknown. Limited information was available over the call. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
tested positive for Covid/got her 1st shot of the vaccine and tested positive for COVID ten days later; This is a spontaneous report from a contactable consumer (patient's mother). A 19-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 02Apr2021, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter (patient's mother) reported that the patient (reporter's daughter) received the first dose of the Pfizer-BioNTech COVID-19 Vaccine on 02Apr2021 and tested positive for COVID 10 days later, on 12Apr2021. She wanted to know the timeframe for when her daughter could receive her second dose. She said she did not have the vaccine card to provide the lot number and expiration date of the product. She also said that her daughter was already recovered and has been out of isolation within the past 2 weeks. The reporter referred to her HCP for further guidance. The reporter declined to complete a report as she had an appointment and did not have time right now, however consents to follow-up. No further information was provided or obtained as reporter requests a transfer to  to address her questions further. There was a product complaint. Outcome of the event was recovered on an unknown date in Apr2021.  Information on the lot/batch number has been requested.
Increased loudness of tinnitus, increased tweaking sounds, increased number of tones heard -- persists to this day (7 months later) Ear congestion, bilateral -- began after about 2 months, persists to this day Ear pain, primarily right side -- began after 4 months, persists to this day
herpes zoster; Information has been received regarding a case in litigation referring to a patient (pt.) of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 18-AUG-2016, the pt. was inoculated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route of administration was not specified) for the long-term prevention of shingles and zoster-related conditions as prescribed and/or administered by a health care professional (HCP) at a primary care provider (PCP) office. On an unspecified date, the pt. claimed to be treated for herpes zoster and claimed damages as a result of injury to itself and economic losses. The outcome of the event was not reported. The reporter considered the evens to be related to zoster vaccine live (ZOSTAVAX).
Patient states the day after she received the flu vaccine she developed joint pain of her extremities, shoulder and neck area. She then noticed approximately 10-14 days later becoming short of breath which seemed to gradually become worse and had left sided chest pain which made her have a hard time taking a deep breath. She was seen by her PCP approximately mid November and subsequently was referred to a Cardiologist and Pulmonogist due to continued shortness of breath. Patient states multiple tests were done that were normal. Referred to a Rheumatologist 1/6/4. Labs showed ANA positve, ANA titer 1:320. Patient continues to be short of breath and presently being treated with prednisone. Patient states MD feels she will need to continue steroids for one year. Employee has been out of work since the beginning of December.
My husband was living at home and able to perform normal daily activities until the morning of May 13th when he woke up in his bed at home. He got out of bed to go to bathroom and ended up on floor due to no use of left side. I called emergency services and they took him to hospital ER where he was diagnosed with a stroke. His left side is still not functioning and he was sent to rehab facility for after stroke rehab to relearn use of his left side. The stroke occurred within 20 days of his second dose of the Moderna vaccine.
Faint feeling, sweating, diarrhea, swollen tongue, hot, and nauseas, shaking, pallor, upset stomach.
CHRONIC SINUSITIS; COUGH; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: sinus issues, glaucoma/ocular hypertension, migraine headaches, and hypothyroidism. The patient experienced benign cyst on pituitary gland, flu like symptoms, headache, pain behind eyes and pressure in sinuses nose/eye area (events dose number in series 1) when received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, 1 total, batch number: 1805020, expiry: unknown) dose was not reported, 1 total administered on 05-APR-2021 to left arm for prophylactic vaccination (Dose number in series 1). Treatment medications included diphenhydramine hydrochloride/paracetamol (Tylenol PM) for flu like symptoms. On 23-JUN-2021, It was reported that patient went to ENT (Otorhinolaryngology) who (years ago she had seen him for past sinus problems) sent her to have a CT (Computed tomography) scan cyst on pituitary gland. Found a cyst on pituitary gland (benign) but no issues with sinus on scan. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Everything came back normal. Saw neurosurgeon about that and that cyst was unrelated. MRI (Magnetic resonance imaging)) done after second ENT. The results of that was there are no sinus obstruction/disorder. She had chronic sinusitis (has been ongoing).  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1555194, expiry: unknown) dose was not reported, 1 total, administered to left arm on 03-NOV-2021 for prophylactic vaccination (Dose number in series 2). No concomitant medications were reported.  On an unspecified date, the patient started up again was very bad, Constant drainage down the back of her throat causing cough. Clear mucous bad at night (when lying down) chronic sinusitis (events dose number in series 2). On 08-NOV-2021, the patient went to 3rd sinus doctor he said he looked at all the scans and history and he said chronic sinusitis. She got prescribed a nasal spray that seemed to make it worse. She uses saline nasal spray, oxymetazoline hydrochloride (Afrin), diphenhydramine hydrochloride (children's Benedryl cough syrup), pseudoephedrine and guaifenesin (Mucinex). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from cough, and chronic sinusitis. This report was non-serious. This case, involving the same patient is linked to 20211238505.
Physician reported that a patient inadvertently received an extra dose of menactra. The patient received the first dose on 15-Nov-2021 and a second dose on 28-Mar-2022 with no reported adverse event; Initial information received on 28-Mar-2022 regarding an unsolicited valid non-serious case received from a physician.   This case involves a 11-year-old male patient who received an extra dose of meningococcal A-C-Y-W135 (D conj) vaccine [Menactra]. The patient received the first dose on 15-nov-2021 and a second dose on 28-mar-2022 with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 15-Nov-2021, the patient received a dose Menactra (strength, route, formulation, lot number, expiry date, administration site: unknown). On 28-Mar-2022 he received a extra dose of 0.5 ml total once a day of the same vaccine (strength, formulation, expiry date, administration site: unknown) lot U7208AB via intramuscular route for prophylactic vaccination.  On 28-Mar-2022 physician reported that  patient inadvertently received an extra dose of menactra (extra dose administered) (Latency: same day) after 4 months 13 days approximately of first dose of Menactra. The caller reported that there have been no adverse effects since it was administered on 15-Nov-2022 and 28-Mar-2022.  Action taken was not applicable  Outcome was Unknown   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 the guidelines. 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.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On 21-MAR-2013, the patient was vaccinated with a single dose of ZOSTAVAX (Lot number, expiry date and dose were not reported), subcutaneously. Approximately on an unknown date in March 2013, the patient experienced unspecified inflammation. The patient sought medical attention (details unspecified) for the same and was prescribed MEDROL dose pack. The outcome of unspecified inflammation was reported as not recovered/not resolved. Additional information is not expected.
Left arm pain in armpit; swollen lymph nodes; led to whole left arm pain; This is spontaneous report from a contactable nurse (patient). A 48-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular on left arm single dose for COVID-19 immunization on 10Jan2021, 09:30 AM, at 48-year-old. Medical history and concomitant medication were not reported. No known allergies. The patient did not have COVID prior vaccination. The patient did not have other vaccine in four weeks. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular on left arm for COVID-19 immunization on 20Dec2020, 05:30 PM, at 48-year-old. On 11Jan2021, 05:00 PM, the patient had left arm pain in armpit with swollen lymph nodes, led to whole left arm pain. No treatment received. The patient was not tested for COVID post vaccination. Action taken for BNT162B2 was not applicable. Outcome of the events was not resolved.   Information on the lot/batch number has been requested.
3 days after getting 1st covid vaccine I started have tachycardia and bradycardia episodes and a tight feeling in my chest.
Fever, nausea, headache, aches and pain.  Could not sleep all night
SUPERFICIAL KERATITIS; This spontaneous case was reported by a consumer and describes the occurrence of KERATITIS (SUPERFICIAL KERATITIS) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa.    No Medical History information was reported.   On 15-Mar-2021, the patient ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram. On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. In May 2021, the patient experienced KERATITIS (SUPERFICIAL KERATITIS). At the time of the report, KERATITIS (SUPERFICIAL KERATITIS) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment details were not reported.  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.
Feet/Ankles:  ? extreme coldness sensation,  ? pins/needles,  ? tingling,  ? stinging, ? burning, ? parts of feet feel numb (top of left foot, left and right big toes, ball of right foot),  ? electric shocks in toes, at times top of feet and ankles,  ? sensation of feet vibrating,  ? pain, ? blueish/purpleish blotches/spots on tops of both feet  Legs:  ? feel as if they are vibrating mostly lower legs but starting to feel it up into my thighs,  ? electric shocks in left and right shins and calves, ? stinging, pricks, pins/needles ? burning in calves and shins, ? cold spots that move around my leg (from side of knee to back of leg), ? feels like a sock has been pulled up over my left calf/shin, ? muscles feel tight and sometimes sore, ? sometimes legs feel heavy but not all the time, ? pins/needles and/or crawling sensation, ? calf feels like small cramps/squeezing  Hands/Forearms: ? extreme coldness intermittently in hands, ? stinging in fingertips and palm intermittently, ? burning/pins/needles in fingertips/palm and forearms and wrist, ? Left thumb twitching (started Sunday, Sept. 11), ? Electric zaps at times in fingertips, ? Cold spots on elbows that come and go, ? Icey/burning sensation mainly left wrist, forearm, and upper arm  Treatments tried gabapentin, supplements, naproxen over the last 11 months
Hard, red swelling, with whitish blue center. Hive all over body. 6 hours after injection. TX: Tylenol PRN; Benadryl PRN